IMP,TSV,4.7,11.5,MTX,MG
Report
- Report Number
- 0002023141-2023-02873
- Event Type
- Injury
- Date Received
- October 12, 2023
- Date of Event
- June 18, 2023
- Report Date
- March 19, 2024
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024020009
- PMA / PMN Number
- K101977
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. B4: DATE OF THIS REPORT WAS UPDATED. B5: EVENT DESCRIPTION WAS UPDATED. D1: BRAND NAME WAS UPDATED. D4: CATALOG NUMBER. LOT NUMBER, EXPIRATION DATE AND UNIQUE DEVICE IDENTIFIER (UDI) NUMBER WERE UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G4: PMA/510(K) NUMBER WAS UPDATED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K101880 H2: TYPE OF FOLLOW UP WAS UPDATED. H4: DEVICE MANUFACTURE DATE WAS UPDATED. H10: NARRATIVE/DATA WAS UPDATED. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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: H6: TYPE OF INVESTIGATION CODES WERE ADDED: 4109, 4111, 4114 AND 3331. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 4315. ZIMVIE DID NOT RECEIVE THE REPORTED IMPLANT 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 WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1250209. 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 1250209 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 LONG-TERM PARAFUNCTIONAL HABITS (E.G., CLENCHING, BRUXISM, AND OVERLOADING) OF THE PATIENT OVER THE IMPLANTATION PERIOD ¿ PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED. 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 PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A2: AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. A3: PATIENT SEX UNKNOWN / NOT PROVIDED. A4: WEIGHT UNKNOWN / NOT PROVIDED. D1: BRAND NAME UNKNOWN / NOT PROVIDED. D4: CATALOG AND LOT NUMBER UNKNOWN / NOT PROVIDED. G4: PMA/510(K) NUMBER NOT AVAILABLE. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS. HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
UPON FOLLOW UP, THE CATALOG NUMBER AND LOT NUMBER WERE PROVIDED.
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE IMPLANT CROWN BECAME LOOSE AGAIN. AT THIS TIME, WE REFERRED THE PATIENT FOR FURTHER EVALUATION AS TO WHY THIS IS REOCCURRING. THE REFERRAL DOCTOR THEN CALLED THE RESTORING DOCTOR AND ADVISED THAT THE IMPLANT BODY HAD FRACTURED ON THE BUCCAL SURFACE OF THE IMPLANT BODY. THE DOCTOR CONFIRMED REPLACING THE IMPLANT BODY WITH ANOTHER IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1414981 | IMP,TSV,4.7,11.5,MTX,MG | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 1250209 | 00889024020009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Prefer Not To Disclose | Required Intervention |