BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSV ANGLED SCREW CHANNEL DRIVER 24MM

    MDR report key: 24965083 · Received April 23, 2026

    Report

    Report Number
    0001038806-2026-02224
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 20, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    NDP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). D4: ADDITIONAL DEVICE INFORMATION UNKNOWN / NOT PROVIDED. H4: DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DRIVER WAS FRACTURED AT THE TIP. NO IMPACT ON THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499202 TSV ANGLED SCREW CHANNEL DRIVER 24MM DENTAL DRIVER NDP ZIMVIE US CORP LLC

    Patients

    Seq Age Sex Outcome Treatment
    1