IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM
Report
- Report Number
- 0002023141-2025-01261
- Event Type
- Injury
- Date Received
- May 13, 2025
- Date of Event
- March 14, 2025
- Report Date
- July 22, 2025
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024020092
- PMA / PMN Number
- K061410
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT D1: BRAND NAME D4: CATALOG NUMBER D4: LOT/SERIAL # D4: DEVICE EXPIRATION DATE D4: DEVICE UDI NUMBER D9: DEVICE AVAILABILITY G3: DATE RECEIVED BY MANUFACTURER G4: ADDITIONAL PMA/510(K) NUMBER K011028,K013227 G6: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H4: DEVICE MANUFACTURER DATE H10: ADDED MANUFACTURER NARRATIVE.
ZIMVIE COMPLAINT NUMBER: (B)(4). G4: ADDITIONAL PMA/510(K) NUMBER K013227.
ZIMVIE RECEIVED ONE (1) (B)(6), (IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE, APPARENT BONE / TISSUE ATTACHED TO EXTERNAL THREADS. IMPLANT FRACTURE IDENTIFIED AT THE COLLAR. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENTS COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENTS. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1260816. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1260816 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿FRACTURE IMPLANT¿ & ¿BONE LOSS¿ THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENTS. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RMF RM-00541-HAZ REV. 5, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE PARAFUNCTIONAL HABITS/PATIENT FACTORS. REFER TO ATTACHED SUMMARY INVESTIGATION FOR ¿BONE LOSS¿ THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENT (FRACTURE IMPLANT) WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. BONE LOSS IS A MEDICAL CONDITION AND IS NON-VERIFIABLE WITH THE INFORMATION PROVIDED. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCTS WERE NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. SIMILAR COMPLAINTS FOR BONE LOSS RELATED PROBLEMS 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. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS ESCAPING THE AVAILABLE DETECTIONS IS REMOTE AND ALMOST NONEXISTENT. 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. 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. 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.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS AND FRACTURE. CUSTOMER REPORTED PATIENT WAS HAVING PAIN WHILE BITING DOWN. TOOK AN X-RAY AND SAW BONE LOSS AROUND THE IMPLANT. IMPLANT HAD EXTREME BONE LOSS AND FOUND TO BE FRACTURED. DID AN EXTRACTION AND NOTICED THE IMPLANT WAS FRACTURED, TOOTH 13. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2370021 | IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 1260816 | 00889024020092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Unknown | Required Intervention |