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 INFORMATION |
Placement Date *:
( dd / mmm / yyyy )
|
Event Date *:
( dd / mmm / yyyy )
|
Removal Date *:
( dd / mmm / yyyy )
|
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 ( LI ) |
Other , please detail :_________________________ |
Provide a detailed description of the reported problem ( including procedure being performed , related products and settings used )*:
_________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________
At the time of the event or implant failure / removal , was there …? ( Check all that apply ) *: Was surgical and / or medical intervention necessary to preclude permanent impairment ?*
No Patient Impact Abscess Ingestion Aspiration Paresthesia Yes No If Yes , please describe :
Was there a delay during the procedure ?* |
Yes |
No If Yes , please describe : |
Will the patient have to return for an additional dental appointment to complete |
Yes |
No If Yes , please describe : |
the procedure ?* |
|
|
Was the procedure completed using another implant or another device ?* |
Yes |
No If Yes , please describe : |
Other Relevant Patient History ( Check all that apply )*:
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 : ____________
Pain Edema
Inflammation Other : ________ 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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