bredent medical GmbH & Co.

KG
Retouren-Service-Center
Weissenhorner Str. 2
D-89250 Senden

Documentation form for non-osseointegration guarantee

As a voluntary service, bredent medical offers a non-osseointegration guarantee for its implants.The
guarantee covers a free replacement delivery for non-osseointegrated SKY implants from bredent
medical.A credit is not possible.

For this service, the following requirements must be met:

 Fully completed documentation form for each patient.Different implant losses for one patient
can be recorded on a single form.
- Dealer information (export sales only)
- Name and address of the practitioner(s)
- Anonymous information about the patient with information about the general health risks
of the patient
- Information on implantation and restoration
- Information on explantation and possible causes of non-healing

Important:Without the batch number of the explanted implant, the procedure cannot be
processed.

 Submission of the removed implant in cleaned condition

 Presentation of a copy of a corresponding X-ray image (anonymisation required)

The cause of the loss is irrelevant for the use of the non-osseointegration guarantee.On behalf of
our Research & Development, we ask you to determine and describe the clinical data that led to the
loss as accurately as possible.This data is recorded in a special program and will be evaluated
regularly for quality assurance purposes.

Exclusion of guarantee

Implants that could not be inserted with primary stability during the operation and therefore have to
be removed on the same day and replaced by a larger diameter implant are not covered by this
guarantee.The same applies to implants that became unsterile during the operation because they
fell on the floor, for example.

For hygienic reasons and to avoid any potential risk of infection for our employees, please note that
our non-osseointegration guarantee for non-osseointegrated implants ONLY comes into force if the
implants are cleaned and returned to us in functional and undamaged sterile packaging prior to
return.

If these conditions are not met, the NOI implants sent in will be disposed of immediately and without
exception, and the guarantee case will not be processed.A free replacement delivery to you can
therefore also not take place in these cases!

Tel. (+49) 0 73 09 / 8 72-6 00 Managing director: VAT ID number:DE247337738 HypoVereinsbank Ulm Commerzbank Ulm
Fax (+49) 0 73 09 / 8 72-6 35 Peter Brehm Personally liable partner: HYVEDEMM461 COBADEFF630
Email info-medical@bredent.com Gerald Micko bredent medical Verwaltungs- und DE16 6302 0086 0314 0372 00 DE58 6304 0053 0922 3041 00
Web www.bredent-medical.com Olaf Glück Handels-GmbH, Senden
Nils Brehm
Non-osseointegration guarantee documentation form,

If prosthetic abutments or other parts installed with the implant are sent in together with the implant,
we will NOT return them. Furthermore, there is no right to compensation or the like for these other
parts.

Please return the enclosed documentation form to the address listed below as soon as possible so
that we can process the process quickly and unbureaucratically.

Note on data protection:

As a precaution, we would like to point out that you may only transfer the patient’s name to us if the
patient has released you as the practitioner of your medical or dental duty of confidentiality.

In this case, please send a copy of the written declaration of consent.A transmission of the
requested data with patient names and without such a consent can be punishable in accordance
with § 203 Paragraph. 1 of the StGB (Criminal Code) and also represent a offence against your
professional duty of confidentiality.

When you sending the requested data or information, please ensure that no names of the patients
concerned are recognisable or that they are made unrecognisable.Please understand that for legal
reasons we will destroy any documents with clear names and without a declaration of consent
without taking note of their content.

For communication about the case, we suggest using patient number.The transmission of the
requested data and information in accordance with the General Data Protection Regulation (GDPR)
takes place on the legal basis of Art. 9 Para. 2 h) of the GDPR.We would like to point out that
according to Art. 12 of the GDPR, you are obliged to inform the patient about the transmission to us.

With kind regards,

Retouren-Service-Center

bredent medical GmbH & Co KG

Retouren-Service-Center
Weissenhorner Str. 2
89250 Senden

Tel. (+49) 0 73 09 / 8 72-6 00 Managing director: VAT ID number:DE247337738 HypoVereinsbank Ulm Commerzbank Ulm
Fax (+49) 0 73 09 / 8 72-6 35 Peter Brehm Personally liable partner: HYVEDEMM461 COBADEFF630
Email info-medical@bredent.com Gerald Micko bredent medical Verwaltungs- und DE16 6302 0086 0314 0372 00 DE58 6304 0053 0922 3041 00
Web www.bredent-medical.com Olaf Glück Handels-GmbH, Senden
Nils Brehm
Non-osseointegration guarantee documentation form,

Documentation form for non-osseointegration

Please use a separate documentation form for each patient.Please complete all the information on the
implants placed and explanted.
Attention:Processing is not possible without batch numbers.

Surgeon Prosthodontist
Customer no.: _________________________ Customer no. _____________________
(Only complete if no customer number exists at bredent medical)

Name _________________________ Name: _____________________

Street: _________________________ Street: _____________________
Location: _________________________ City: _____________________
Telephone: _________________________ Telephone: _____________________
Fax: _________________________ Fax: _____________________
Email: _________________________ Email: _____________________

Patient (please note our privacy policy)

First name (initials):_______ Surname (initials): ______
Date of birth:_______________ (dd/mm/yyyy)
Gender: male  female

General risk factors of the patient

 Acute periodontitis  Cortisone on a regular basis  Osteoporosis

 Alcoholism  Cytotoxic medication  Psychological problems
 Allergy:Nickel  Diabetes requiring insulin  Smoker 0 - no
 Allergy:Penicillin  Drugs  Smoker 1 – casual (1–5/day)
 Allergies  Dysgnathy  Smoker 2 – moderate (6–15/day)
 Adult-onset diabetes  Endocarditis  Smoker 3 – heavy (16+/day)
 Anaemia  Epilepsy  Acid refluxHeartburn
 Anxiety  Anticoagulant  Rheumatoidarthritis
 Antidepressants  Halitosis  Thyroid disorders
 Asthma  Hepatitis A  Sleep disorders
 Tranquillisers  Hepatitis B  Mucosal disorders
 Irradiation 1 - (30 Gray)  Hepatitis C  Snoring
 Irradiation 2 - (30–50 Gray)  Cardiac arrhythmias  Pregnancy
 Irradiation 3 - (>50 Gray)  Cardiac insufficiency  Fissures and craniofacial malformations
 Bisphosphonates  Pacemaker  Steroids
 Anticoagulants  HIV  Stress
Medication  Hypertension  Trauma
 Blood sugar  Hypotension  Tumour
 Bruxism  Coagulopathies  Hypersensitive teeth
 Chronic periodontitis  Malnutration  Xerostomia

Oral hygiene status

 Normal
 Mild inflammation
 Moderate inflammation
 Severe inflammation Page 1 of 2

Tel. (+49) 0 73 09 / 8 72-6 00 Managing director: VAT ID number:DE247337738 HypoVereinsbank Ulm Commerzbank Ulm
Fax (+49) 0 73 09 / 8 72-6 35 Peter Brehm Personally liable partner: HYVEDEMM461 COBADEFF630
Email info-medical@bredent.com Gerald Micko bredent medical Verwaltungs- und DE16 6302 0086 0314 0372 00 DE58 6304 0053 0922 3041 00
Web www.bredent-medical.com Olaf Glück Handels-GmbH, Senden
Nils Brehm
Non-osseointegration guarantee documentation form,

Implantation
Implantation date:______________ (dd/mm/yyyy)
(Please indicate all implants placed – either in the table or on the graphic)

Position Implant REF Lot number: Bone Explanted

quality:
D1 – D4









Temporary restoration
 Without  With crowns/bridges except occlusion
 Without splint  With crowns/bridges with load
 With prosthesis 

Explantation
Date Position Granulation Causes Possible causes of loss
tissue (Please indicate BG = Bindegewebseinheilung [connective tissue
abbreviation) healing]
 BR = Breakage
DN = Drucknekrose [pressure necrosis]
 
FB = Frühbelastung [early loading]
  FP = Fehlende Primärstabilität [lack of primary
  stability]
  KB = Kieferbruch [fracture of the jaw]
  KN = Knochennekrose [bone necrosis]
  KO = Keine Osseointegration [no
  osseointegration]
NV = Nervverletzung [nerve injury]
  PD = Prothesendruck [prosthesis pressure]
  PI = Provisorisches Implantat [temporary
  implant]
RA = Rauchen [smoking]
SL = Spontaneous loss
ÜB = Überlastung [overload]

Comments: _____________________________________________________________
_____________________________________________________________
_____________________________________________________________
Please return the documentation form together with explanted implants and a copy of the anonymised X-ray
to: bredent medical GmbH & Co KG
Retouren-Service-Center Page 2 of 2
Weissenhorner Str. 2
89250 Senden
Tel. (+49) 0 73 09 / 8 72-6 00 Managing director: VAT ID number:DE247337738 HypoVereinsbank Ulm Commerzbank Ulm
Fax (+49) 0 73 09 / 8 72-6 35 Peter Brehm Personally liable partner: HYVEDEMM461 COBADEFF630
Email info-medical@bredent.com Gerald Micko bredent medical Verwaltungs- und DE16 6302 0086 0314 0372 00 DE58 6304 0053 0922 3041 00
Web www.bredent-medical.com Olaf Glück Handels-GmbH, Senden
Nils Brehm