M05.01.01.01 Rev . 30
PRODUCT EXPERIENCE REPORT
Effective Date : June 13 , 2022
For Zimvie Use Only Not to be Completed by the Reporter CMP #:
PRODUCT EXPERIENCE REPORT
The inclusion of as many details as possible greatly aids the investigation process , continuous improvement and is necessary to comply with Medical Device Manufacturer Regulatory Requirements . Missing information will delay processing . Required fields are identified with an asterisk (*).
Document if a Complaint # has been previously assigned
CMP #: _______________
A . EVENT Placement Date *:
Event Date *: Removal Date *:
( dd / mmm / yyyy ) ( dd / mmm / yyyy )
( dd / mmm / yyyy )
INFORMATION Discovered *: During receiving / unpacking During clinical procedure During Laboratory Procedure
Other :_________________
Description of the Event ( Check all that apply )* Allergic Reaction Infection Nerve Injury Peri-implantitis Bone Loss Lack of Primary Stability Non-Integration ( NI ) Sinus Perforation Fracture Loss of Integration
Discovery date
( LI ) Other , please detail :_________________________
Provide a detailed description of the reported problem ( including procedure being performed , related products and settings used )*:
Integrated or not . Final prosthetics or not ? Description please _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________
At the time of the event or implant |
No Patient Impact |
|
failure / removal , was there …? ( Check all that apply ) *:
What happend to the patient ?
|
Abscess
Aspiration
|
Ingestion
Paresthesia
|
Pain
Edema
|
Inflammation
Other : ________
|
Was surgical and / or medical intervention |
|
|
|
|
|
necessary to preclude permanent impairment ?*
Any special surgery ?
|
Yes |
No If Yes , please describe : |
Was there a delay during the procedure ?* |
Yes |
No If Yes , please describe :
Did the surgery take extra long time ?
|
Will the patient have to return for an additional dental appointment to complete the procedure ?* |
Yes |
No If Yes , please describe :
Need of extra appointment ?
|
Was the procedure completed using another implant or another device ?* |
Yes |
No If Yes , please describe : |
Did you replace the implant ? |
Other Relevant Patient History ( Check all that apply )*: Please fill in relevant information
Tooth Number * Tooth Number *
Additional Information :
______ Universal FDI Palmer
______ Universal FDI Palmer
Grafted prior to implant placement Grafted together with implant placement Bruxism Clenching
Other : ____________
Bone Density Type *
Diabetes Osteoporosis
Site Grafted If Yes , Describe Material Graft placement date : ____________
Smoker / Tobacco use Inadequate Oral
Hygiene I II III IV Unknown Allograft Autogenous Xenograft
Alloplast Hybrid
Note : This information is being gathered to assist in complying with regulatory requirements in the USA and other countries as applicable . Completion of this form does not constitute an admission that medical personnel , distributor , manufacturer , or product caused or contributed to the event .
Template D01.02.00.03 Rev 2 , Eff . Date : March 02,2022 Ref .
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