BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM

    MDR report key: 24647802 · Received March 20, 2026

    Report

    Report Number
    0001038806-2026-01494
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    January 15, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019577
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: PREMARKET IDENTIFICATION K013227.

    Description of Event or Problem · 0

    THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN POSITION NUMBER 46 FAILED BECAUSE IT FRACTURED AT THE HEAD. IMPLANT WAS REMOVED. THE DOCTOR REPORTS THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458155 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1257511 00889024019577

    Patients

    Seq Age Sex Outcome Treatment
    1