BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    MDR report key: 24577968 · Received March 12, 2026

    Report

    Report Number
    0001038806-2026-01324
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    February 16, 2026
    Report Date
    April 24, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: PREMARKET IDENTIFICATION K011028/K013227.

    Description of Event or Problem · 0

    THE DOCTOR REPORTED A FRACTURE OF THE BUCAL BONE WALL DURING THE IMPLANT PLACEMENT. THE AFFECTED TOOTH POSITION IS NUMBER #14, AND THERE WAS NO NEGATIVE IMPACT ON THE PATIENT¿S HEALTH. THE PROCEDURE WAS NOT COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122650 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1301512 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown