BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM

    MDR report key: 24606271 · Received March 16, 2026

    Report

    Report Number
    0001038806-2026-01411
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    January 23, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024020092
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: ADDITIONAL PMA/510(K) NUMBER: K011028, K013227.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MOUNT WON'T COME OFF. AFTER PLACEMENT, THE MOUNT DID NOT DETACH AND WAS REMOVED; THE SAME PRODUCT WAS REINSERTED. PROCEDURE COMPLETED USING ANOTHER DEVICE, REINSERTION PERFORMED USING AN IDENTICAL PRODUCT FROM INVENTORY. TOOTH SITE # 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77723 IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1287268 00889024020092

    Patients

    Seq Age Sex Outcome Treatment
    1