TSX IMPLANT, 3.1MMD, 11.5MML
Report
- Report Number
- 0001038806-2025-01270
- Event Type
- Injury
- Date Received
- June 5, 2025
- Date of Event
- April 14, 2025
- Report Date
- August 19, 2025
- Manufacturer
- BIOMET 3I
- Product Code
- DZE
- UDI-DI
- 00844868045007
- PMA / PMN Number
- K220978
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMVIE COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN / NOT PROVIDED. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMVIE FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA AND ADDITIONAL INFORMATION. CORRECTION: THE ITEM NUMBER WAS UPDATED FROM TSX37B11 TO TSX31B11. H6 METHOD CODE 4109 AND 4111 WERE REMOVED AND UPDATED TO 4118. H6 RESULTS CODE 213 WAS REMOVED AND UPDATED TO 3233. H6 CONCLUSIONS CODE 4310 WAS REMOVED AND UPDATED TO 11. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. D1: BRAND NAME WAS UPDATED. D4: UNIQUE DEVICE IDENTIFIER (UDI) NUMBER, CATALOG NUMBER, LOT NUMBER AND EXPIRATION DATE WERE UPDATED. D9: DEVICE AVAILABILITY AND RETURN DATE WERE UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H4: DEVICE MANUFACTURE DATE WAS UPDATED. H6: TYPE OF INVESTIGATION METHOD CODE WAS ADDED: 4118. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 3233. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 11. H10: NARRATIVE/DATA WAS UPDATED. PRODUCT HAS BEEN RECEIVED BY ZIMVIE AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR 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 CODES WERE ADDED: 4109, 4111 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 67 AND 4315. H10: NARRATIVE/DATA WAS UPDATED. ZIMVIE RECEIVED THE REPORTED IMPLANT FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED, THE IMPLANT HAD SIGNS OF USE WITH DEBRIS ON ITS INTERNAL AND EXTERNAL THREADS. THERE WAS NO DAMAGE IDENTIFIED OR SIGNS OF MALFUNCTION THAT WOULD HAVE CONTRIBUTED TO THE EVENT. MEASUREMENTS MATCH DRAWING. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER. 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 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSE DETERMINED FROM THE INVESTIGATION WAS INADEQUATE TREATMENT PLANNING. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR. NO DAMAGE TO THE IMPLANT WAS IDENTIFIED. THE REPORTED EVENT WAS 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.
IT WAS REPORTED THAT TEETH #6 AND #8 WERE EXTRACTED WITH IMMEDIATE GUIDED IMPLANT PLACEMENT USING IMPLANT CONCIERGE. THE #6 IMPLANT WAS PLACED TOO FACIAL AND THE PATIENT EXPERIENCED DISCOMFORT FOR 3-4 WEEKS. THE IMPLANT WAS REMOVED DUE TO PAIN AND A NEW IMPLANT WAS REPOSITIONED MORE PALATAL. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION & PAIN.
UPON FOLLOW UP, THE REPORTED ITEM NUMBER WAS UPDATED.
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1631344 | TSX IMPLANT, 3.1MMD, 11.5MML | DENTAL IMPLANT | DZE | BIOMET 3I | 2120019330 | 00844868045007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Unknown | Required Intervention |