IMP,TSV,4.1MM,SBM,11.5
Report
- Report Number
- 0002023141-2024-03725
- Event Type
- Injury
- Date Received
- November 18, 2024
- Date of Event
- September 30, 2024
- Report Date
- March 19, 2025
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019232
- PMA / PMN Number
- K072589
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. CORRECTION: THE IMPLANT PLACEMENT DATE WAS UPDATED/CORRECTED TO (B)(6) 2024. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. D6A. IMPLANTATION DATE WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODE WAS ADDED: 3331, 4110, AND 4114. H10: NARRATIVE/DATA WAS UPDATED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. STERILIZATION RECORD WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. AS DOCUMENTED IN THE SUMMARY INVESTIGATIONS, CONTRIBUTING FACTORS FOR THE REPORTED EVENT LIKELY EXIST OUTSIDE OF ZIMVIE CONTROL, INCLUDING THOSE RELATED TO PATIENT BIOLOGICAL FACTORS/CONDITION AND SURGICAL TECHNIQUE. BASED ON THE SUMMARY INVESTIGATIONS, NO MALFUNCTION OCCURRED UPON INVESTIGATION. THE REPORTED EVENTS REMAIN NON-VERIFIABLE AS THEY ARE A MEDICAL CONDITION. MONTHLY TRENDING TO DATE HAS NOT IDENTIFIED ANY STATISTICAL TRIGGERS SUGGESTING POTENTIAL DESIGN OR MANUFACTURING RELATED ISSUES. PREVIOUSLY COMPLETED INVESTIGATIONS FOR INFECTION, BONE LOSS, AND/OR PERI-IMPLANTITIS PROBLEMS REPORTED IN ASSOCIATION WITH IMPLANT FAILURE HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES IMPACTING THE MANUFACTURING AND STERILIZATION PROCESSES. THEREFORE, ESCALATION TO CAPA IS NOT REQUIRED.
ZIMVIE COMPLAINT NUMBER: (B)(4). G4: ADDITIONAL PMA/510(K) NUMBER - K072589. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR THESE EVENTS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCE'S AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO PERI-IMPLANTITIS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NON-EXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED. H3 OTHER TEXT: SUMMARY INVESTIGATION.
UPON FOLLOW UP, THE IMPLANT PLACEMENT DATE WAS UPDATED.
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO PERI-IMPLANTITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2036418 | IMP,TSV,4.1MM,SBM,11.5 | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 1283070 | 00889024019232 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Required Intervention |