BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1,11.5,MTX,MG

    MDR report key: 20625981 · Received November 6, 2024

    Report

    Report Number
    0002023141-2024-03535
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    September 15, 2024
    Report Date
    March 18, 2025
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019836
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D4: ADDITIONAL DEVICE INFORMATION. D9: DEVICE AVAILABILITY. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H4: DEVICE MANUFACTURER DATE. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVE. ZIMVIE RECEIVED ONE (1) TSVT4B11, (IMP,TSV,4.1,11.5,MTX,MG) FOR EVALUATION. VISUAL EVALUATION OF THE AS RETURNED DEVICE IDENTIFIED THE IMPLANT WITH SIGNS OF USE. THE IMPLANT WAS OBSERVED SEVERELY DAMAGED AROUND THE EXTERIOR THREADS, LIKELY DUE TO THE REMOVAL PROCESS, AND WAS SEEN FRACTURED AT THE COLLAR REGION. ADDITIONALLY, A FRACTURED SCREW FRAGMENT WAS NOTICED STUCK INSIDE THE IMPLANT. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENTS. THIS COMPLAINT REFERS TO THE SPECIFIC DEVICE BEING INVESTIGATED FOR THIS COMPLAINT RECORD. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1253797. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENTS, WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 1253797 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DAMAGED DRIVE FEATURE AND FRACTURE IMPLANT. THE CUSTOMER DID NOT SUBMIT IMAGES FOR THE REPORTED EVENTS. BASED ON THE INVESTIGATION AND RISK MANAGEMENT FILE REVIEWS, THE MOST LIKELY ROOT CAUSES DETERMINED FROM THE INVESTIGATION ARE PARAFUNCTIONAL HABITS/PATIENT FACTORS, AND INCORRECT TECHNIQUES USED - CUSTOMER ERROR. THEREFORE, BASED ON THE AVAILABLE INFORMATION, A DEVICE MALFUNCTION DID OCCUR. THE REPORTED EVENTS WERE 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. 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.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4).

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT STRIPPED AND BROKE. TOOTH NUMBER 19. THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997786 IMP,TSV,4.1,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1253797 00889024019836

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention