IMP,TSV,4.7,11.5,MTX,MG
Report
- Report Number
- 0002023141-2024-00164
- Event Type
- Injury
- Date Received
- January 25, 2024
- Date of Event
- January 11, 2023
- Report Date
- June 10, 2024
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024020009
- PMA / PMN Number
- K101977
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). IT WAS REPORTED THAT THE TOP PART GOT STUCK, COULDN'T GET REMOVED. AFTER PLACEMENT THE TOP PART WAS STUCK, TRIED TO REMOVE THE SCREW BUT IT CAME OUT WITH THE IMPLANT. OSTEOTOMY WAS WIDENED AND HAD TO REPLACE WITH ANOTHER IMPLANT. UNKNOWN TOOTH NUMBER. ZIMVIE DID NOT RECEIVE ONE (1) TSVTWB11, (IMP,TSV,4.7,11.5,MTX,MG) 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). FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1251744. 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 1251744 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DOES NOT DISENGAGE/RELEASE & PERFORATED SINUS. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENTS. IFU REVIEW: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE ¿ TAPERED SCREW-VENT® AND TRABECULAR METAL¿ IMPLANTS - 4869 REV. 9-10/19. INFORMATION IDENTIFIED: BREAKAGE & ADVERSE EFFECTS BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEW, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE EXCESSIVE TORQUE APPLIED, CUSTOMER ERROR/PATIENT FACTORS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION COULD NOT BE VERIFIED. WITHOUT DEVICE RECEIPT, THE REPORTED EVENTS WERE 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. AT THIS TIME, THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE RECORD WILL BE CLOSED. IF ADDITIONAL INFORMATION IS RECEIVED, THE RECORD WILL BE RE-OPENED FOR FURTHER EVALUATION.
ZIMMER BIOMET COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. A2: PATIENT AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K101880. THE DEVICE WILL NOT 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.
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
IT WAS REPORTED AT IMPLANT PLACEMENT THE TOP PART/SCREW WAS STUCK (CAPTURED IN (B)(4)), TRIED TO REMOVE THE SCREW BUT IT CAME OUT WITH IMPLANT. THE OSTEOTOMY WAS WIDENED AND HAD TO REPLACE WITH ANOTHER IMPLANT. THE PATIENT EXPERIENCED SINUS PERFORATION AT TWO UNKNOWN IMPLANT TOOTH SITES; HOWEVER, ONLY 1 IMPLANT WAS RETURNED TO MANUFACTURER BECAUSE THE OTHER ONE WAS DISCARDED (RETURNED IMPLANT CASE CAPTURED IN (B)(4)).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1897873 | IMP,TSV,4.7,11.5,MTX,MG | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 1251744 | 00889024020009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |