IMP,TSV,MCOL MG,4.7MM,10M
Report
- Report Number
- 0002023141-2022-00080
- Event Type
- Injury
- Date Received
- January 13, 2022
- Report Date
- May 5, 2022
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024019775
- PMA / PMN Number
- K111889
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL DEVICE INFORMATION UNKNOWN. PMA/510(K) NUMBER NOT AVAILABLE. SINCE THE LOT NUMBER AND DEVICE WILL NOT BE RETURNED, IDENTIFYING A DEFINITIVE ROOT CAUSE WILL NOT BE POSSIBLE. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH IDENTIFIES THE PRODUCT OR INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4).
ZIMMERBIOMET COMPLAINT NUMBER (B)(4) ONE MOUNT AND MOUNT SCREW FOR TSVMWB10 WERE RETURNED FOR INVESTIGATION. THE IMPLANT WAS NOT RETURNED AND THERE WERE NO ALLEGATIONS AGAINST IT. THIS INVESTIGATION WAS PERFORMED ONLY ON THE MOUNT. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED FRACTURE AROUND THE MOUNT HEX. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE DEVICE WAS INTENDED FOR AND UNKNOWN TOOTH SITE. X-RAY & PICTURE EVALUATION: X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ PROSTHETICS FOR ZIMMER DENTAL IMPLANT SYSTEMS ¿ IFU4894 REV 6 ¿ 08/19. INSTRUCTIONS FOR USE - TAPERED SCREW-VENT AND TRABECULAR METAL IMPLANTS, IFU4869 REV 9-10/19. INFORMATION IDENTIFIED: CONTRAINDICATIONS & PRECAUTIONS. PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUES AS WELL AS SEVERE BRUXISM, CLENCHING, AND OVERLOADING, MAY CAUSE COMPONENT FRACTURE. DHR REVIEW: DHR REVIEW FOR THE LOT (1240797) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1240797) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FUNCTIONAL: FRACTURE: MOUNT) AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: MARCH POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED
DOCTOR REPORTED THAT THE LITTLE FEET OF THE IMPRESSION COPING FRACTURED WHEN PLACING THE IMPLANT.
DOCTOR REPORTED FRACTURED OF THE BODY MOUNT WHEN PLACING IT.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1016400 | IMP,TSV,MCOL MG,4.7MM,10M | DENTAL IMPLANT | DZE | ZIMMER DENTAL | TSVMWB10 | 1240797 | 00889024019775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |