IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM
Report
- Report Number
- 0002023141-2022-01918
- Event Type
- Injury
- Date Received
- July 29, 2022
- Date of Event
- July 18, 2022
- Report Date
- January 27, 2023
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- PMA / PMN Number
- K061410
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ZIMMERBIOMET COMPLAINT NUMBER (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER: K013227. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT: 0002023141-2022-03100-1. THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: H6: TYPE OF INVESTIGATION CODES WERE UPDATED: 3331, 4109, 4110, 4111. H6: INVESTIGATION FINDINGS CODE WAS UPDATED: 3252. H6: INVESTIGATION CONCLUSION CODE WAS UPDATED: 4307. ONE IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM (TSVWB11) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED IMPLANT FRACTURED AT THE COLLAR REGION. BASED ON THE EVALUATION, DEVICE MALFUNCTION HAS OCCURRED. HOWEVER, THERE IS NO EXISTING NONCONFORMANCE / CAPA / HHE/D / IE / PRODUCT HOLD AGAINST THE REPORTED DEVICE THAT DID OR COULD CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. MONTHLY POST MARKET TRENDING REVIEW IDENTIFIED NO ADVERSE TRENDS OR ACTIONABLE TRENDS FOR THE REPORTED EVENT OR DEVICE. ZIMVIE QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, THE PRODUCT WAS WITHIN SPECIFICATIONS AND CONFORMING WHEN IT LEFT ZIMVIE. DHR REVIEW FOR THE LOT (63164592) HAS REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (63164592) FOR SIMILAR EVENTS. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE INVESTIGATION, RISK REVIEW AND IFU, THE MOST LIKELY CAUSES DETERMINED FROM THE INVESTIGATION IS CLINICIAN¿S ERROR WHILE REMOVING IMPLANT. 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.
THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND CORRECTED DATA FROM REPORT: 0002023141- 2022- 01918. CORRECTED DATA: THE PATIENT IDENTIFIER WAS CHANGED TO (B)(6). THE MANUFACTURER DATE WAS CHANGED TO AUGUST 28, 2015 AND THE EXPIRATION DATE WAS CHANGED TO AUGUST 31, 2020. THE REPORTER CONTACT INFORMATION WAS CHANGED TO DR. CIMARA FERREIRA WITH RELEVANT INFORMATION.
CUSTOMER REPORTED A FRACTURED IMPLANT ON TOOTH #19. NO PATIENT IMPACT.
NO ADDITIONAL EVENT INFORMATION WAS RECEIVED AT THE TIME OF THIS REPORT.
UPON FURTHER INVESTIGATION, THE DOCTOR'S OFFICE REPORTED ADDITIONAL PATIENT INFORMATION, EVENT DATE INFORMATION, DEVICE INFORMATION AND DOCTOR CONTACT INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2654238 | IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 63164592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Required Intervention |