IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
Report
- Report Number
- 0002023141-2024-01506
- Event Type
- Injury
- Date Received
- May 9, 2024
- Date of Event
- May 2, 2023
- Report Date
- October 20, 2024
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019508
- PMA / PMN Number
- K061410
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- 003
Narratives
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 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 1242660. 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 1242660 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. A4: WEIGHT UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K011028 / K013227. 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: B4: DATE OF THIS REPORT WAS 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. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODES WERE ADDED: 10. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 3252. H6: INVESTIGATION CONCLUSIONS CODE WAS ADDED: 4307. H10: NARRATIVE/DATA WAS UPDATED. ZIMVIE RECEIVED THE REPORTED IMPLANT FOR EVALUATION. VISUAL EVALUATION WAS PERFORMED. BONE DEBRIS ON EXTERNAL THREADS. DAMAGE TO THE IMPLANT WAS IDENTIFIED. THE IMPLANT HAD A FRACTURED COLLAR. 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 DID OCCUR. THE IMPLANT HAD A FRACTURED COLLAR. THE REPORTED EVENT WAS CONFIRMED WITH ALL THE AVAILABLE INFORMATION. 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.
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
IT WAS REPORTED THAT THE PLATFORM OF THE IMPLANT AT TOOTH SITE #46 WAS FRACTURED AND WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, INFLAMMATION, EDEMA, ABSCESS.
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 520682 | IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 1242660 | 00889024019508 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |