IMP,TSV,MCOL MG,4.7MM,11.5MML
Report
- Report Number
- 0002023141-2024-04160
- Event Type
- Injury
- Date Received
- December 27, 2024
- Date of Event
- December 5, 2024
- Report Date
- April 16, 2025
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- PMA / PMN Number
- K111889
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMVIE COMPLAINT NUMBER (B)(4). G4: PMA/510(K) NUMBER : K111889, K101880.
.IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED AS THE IMPLANT COLLAR WAS FRACTURED. ADDITIONAL INFORMATION WAS OBTAINED VIA PHONE ON (B)(6) 2024, THE CUSTOMER CONFIRMED THE IMPLANT WAS A TSVMWB11 BUT WERE UNABLE TO PROVIDE A LOT. ADDITIONAL INFORMATION WAS OBTAINED VIA DEVICE INSPECTION. THE CUSTOMER RETURNED A TSVWB11 INSTEAD OF THE REPORTED TSVMWB11. ZIMVIE MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE RETURNED IMPLANT. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED. ZIMVIE DID NOT RECEIVE ONE (1) TSVMWB11, (IMP, TSV, MCOL MG,4.7MM, 11.5MML) FOR EVALUATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM NUMBER, DEVICE HISTORY RECORD (DHR) REVIEW, AND RISK MANAGEMENT FILE (RMF). DHR REVIEW BY LOT NUMBER COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. HOWEVER, ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE TSVMWB11 DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/PRODUCT HOLDS FOR THE REPORTED PRODUCT FOR SIMILAR EVENT. REVIEW COMPLETED UTILIZING KEYWORDS: ¿DENTAL: FUNCTIONAL: FRACTURE: IMPLANT¿. THE CUSTOMER DID SUBMIT IMAGES FOR THE REPORTED EVENT. THE IMAGE REVEALED THAT THE IMPLANT WAS FRACTURED AT THE COLLAR. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW AS PER RM-00541-HAZ, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS THE CLINICIAN SELECTS AN IMPLANT THAT IS UNABLE TO RESIST LONG-TERM OCCLUSAL LOADING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION WAS NOT ESTABLISHED. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS NON-VERIFIABLE. 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. 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.
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED AS THE IMPLANT COLLAR WAS FRACTURED. IMPLANT COLLAR FRACTURED & CAUSED IMPLANT FAILURE PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO. SYMPTOMS AS A RESULT OF THE EVENT: NONE.
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1966322 | IMP,TSV,MCOL MG,4.7MM,11.5MML | DENTAL IMPLANT | DZE | ZIMMER DENTAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male | Required Intervention |