IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 8MM
Report
- Report Number
- 0002023141-2024-01416
- Event Type
- Injury
- Date Received
- May 2, 2024
- Date of Event
- February 20, 2024
- Report Date
- September 19, 2024
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024020139
- PMA / PMN Number
- K061410/
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN/NOT PROVIDED G4: ADDITIONAL PMA/510(K) NUMBER ¿ K011028 / K013227. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR BONE LOSS AND INFECTION 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 BONE LOSS AND INFECTION HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS 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.
THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT 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 AND 4110. H10: NARRATIVE/DATA WAS UPDATED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1261510. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. STERILIZATION RECORD OP#(B)(4) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1261510 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS 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 AND/OR BONE LOSS, 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.
IT WAS REPORTED THAT THE PATIENT PRESENTED TWO MONTHS POST IMPLANT PLACEMENT WITH CONTINUED INFLAMMATION AND GINGIVAL SWELLING AROUND THE IMPLANT AT TOOTH LOCATION #3. DEBRIDEMENT AROUND THE AREA WAS ADMINISTERED.
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 841811 | IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 8MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 1261510 | 00889024020139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female | Required Intervention |