IMPL TAPERED SCR-V HA 6MM 5.7MM 11.5MM .
Report
- Report Number
- 0002023141-2024-01352
- Event Type
- Injury
- Date Received
- April 29, 2024
- Date of Event
- September 18, 2023
- Report Date
- September 18, 2024
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019461
- PMA / PMN Number
- K061410
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: PMA/510(K) NUMBER K013227.
SIMILAR COMPLAINTS FOR IMPLANT INFECTION HAVE BEEN PREVIOUSLY INVESTIGATED. REFER TO ATTACHED SUMMARY INVESTIGATION. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PREVIOUSLY RETURNED PRODUCT HAVE NOT IDENTIFIED OR SUGGESTED MANUFACTURING NON-CONFORMANCES. WHILE NON-CONFORMANCES WERE IDENTIFIED FOR SOME LOTS DURING MANUFACTURING RECORD REVIEWS, THE DOCUMENTED DISPOSITION ACTIONS FOR EACH DID NOT SUGGEST THE LIKELY RELEASE OF NON-CONFORMING PRODUCT. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. ADDITIONALLY, ALL DEVICE HISTORY RECORD REVIEWS VERIFIED THAT EACH IMPLANT WAS STERILIZED PER PROCEDURE FOR EVERY DEVICE. ALL COMPLAINT DATA USED FOR THE SUMMARY INVESTIGATION WAS FOUND TO BE CONFORMING AND DID NOT MEET CAPA/HHE/D/ OR ANY FURTHER ESCALATIONS. THEREFORE, THERE WERE NO COMPLAINTS WHICH CONFIRMED A MANUFACTURING OR DESIGN RELATED ISSUE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1250013. 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# 120- STR2 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 1250013 FOR SIMILAR EVENTS AND ONE OTHER COMPLAINT WAS IDENTIFIED (CE-03437-2023). REVIEW COMPLETED UTILIZING KEYWORDS: ¿INFECTION¿ AS DOCUMENTED IN THE SUMMARY INVESTIGATION, 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 INVESTIGATION, NO MALFUNCTION OCCURRED UPON INVESTIGATION. THE REPORTED EVENT REMAINS NON-VERIFIABLE AS IT IS A MEDICAL CONDITION. MONTHLY TRENDING TO DATE HAS NOT IDENTIFIED ANY STATISTICAL TRIGGERS SUGGESTING POTENTIAL DESIGN OR MANUFACTURING RELATED ISSUES. PREVIOUSLY COMPLETED INVESTIGATIONS FOR THE INFECTION OF AN IMPLANT HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES IMPACTING THE MANUFACTURING AND STERILIZATION PROCESSES. THEREFORE, ESCALATION TO CAPA IS NOT REQUIRED. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT D9: DEVICE AVAILABILITY G3: DATE RECEIVED BY MANUFACTURER G6: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H3: CHANGED "NO" TO "YES" H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE.
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #18 SUFFERED FROM INFECTION. PATIENT HAD SWELLING IN FLOOR OF MOUTH/NECK, PAIN SYMPTOMS AS A RESULT OF THE EVENT: PAIN & SWELLING.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1492654 | IMPL TAPERED SCR-V HA 6MM 5.7MM 11.5MM . | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 1250013 | 00889024019461 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female | Required Intervention |