IMP TM 3.7MM MTX,10MM
Report
- Report Number
- 0001038806-2025-03553
- Event Type
- Injury
- Date Received
- December 4, 2025
- Date of Event
- September 22, 2025
- Report Date
- February 2, 2026
- Manufacturer
- ZIMVIE US CORP LLC
- Product Code
- DZE
- UDI-DI
- 00889024018860
- PMA / PMN Number
- K132258
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMVIE COMPLAINT NUMBER (B)(4). ZIMVIE DID NOT RECEIVE ONE (1) TMMB10, (IMP TM 3.7MM MTX,10MM) 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). FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1230816. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1230816 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿FRACTURE IMPLANT¿ THE CUSTOMER DID SUBMIT ONE (1) X-RAY IMAGE FOR THE REPORTED EVENT.. FURTHER REVIEW OF THE CUSTOMER'S X-RAY VERIFIED THE IMPLANT WAS OBSERVED FRACTURED AT THE BODY. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE PARAFUNCTIONAL HABITS/PATIENT FACTORS, OR CUSTOMER ERROR. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS CONFIRMED VIA CUSTOMER'S X-RAY. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS 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.
ZIMVIE COMPLAINT NUMBER (B)(4). ZIMVIE DID NOT RECEIVE ONE (1) TMMB10, (IMP TM 3.7MM MTX,10MM) 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). FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1230816. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1230816 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ¿FRACTURE IMPLANT¿ THE CUSTOMER DID SUBMIT ONE (1) X-RAY IMAGE FOR THE REPORTED EVENT.. FURTHER REVIEW OF THE CUSTOMER'S X-RAY VERIFIED THE IMPLANT WAS OBSERVED FRACTURED AT THE BODY. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE PARAFUNCTIONAL HABITS/PATIENT FACTORS, OR CUSTOMER ERROR. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. WITHOUT DEVICE RECEIPT, THE REPORTED EVENT IS CONFIRMED VIA CUSTOMER'S X-RAY. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA / HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS 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.
ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
DOCTOR REPORTED IMPLANT FRACTURE AT TOOTH SITE 14. IMPLANT FRACTURED IN PATIENT'S JAW; PROSTHESIS CANNOT BE USED ANYMORE. THE BOTTON THIRD PART OF THE IMPLANT REMAINS IN PATIENT'S JAW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1949670 | IMP TM 3.7MM MTX,10MM | DENTAL IMPLANT | DZE | ZIMVIE US CORP LLC | 1230816 | 00889024018860 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female | Required Intervention |