BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TWIST MP-1 3.75 MM 8 MM

    MDR report key: 25056088 · Received May 1, 2026

    Report

    Report Number
    0001038806-2026-02411
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    September 19, 2025
    Report Date
    May 1, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024013117
    PMA / PMN Number
    K013494
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN/NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K943604. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMVIE FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE IMPLANT WAS FIRST PLACED, THE COVER SCREW WAS SEATED UNUSUALLY, BUT IT WAS DETERMINED THAT THIS WAS NOT A PROBLEM. AFTER WAITING FOR OSSEOINTEGRATION, A FRACTURE IN THE COVER SCREW WAS CONFIRMED DURING THE SECOND SURGERY. SINCE IT COULD NOT BE REMOVED, THE ENTIRE IMPLANT WAS EXTRACTED. ACCORDING TO THE PHYSICIAN, THERE WAS NO EXCESSIVE TORQUE APPLIED AND THERE WERE ABSOLUTELY NO TECHNICAL ERRORS. THE PHYSICIAN SPECULATES THAT THE THREADED PORTION OF THE FIXTURE OR COVER SCREW MAY HAVE BEEN DEFECTIVE DURING THE MANUFACTURING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213117 IMPL TWIST MP-1 3.75 MM 8 MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 2022080724 00889024013117

    Patients

    Seq Age Sex Outcome Treatment
    1