BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 24516765 · Received March 5, 2026

    Report

    Report Number
    0001038806-2026-01154
    Event Type
    Injury
    Date Received
    March 5, 2026
    Date of Event
    January 16, 2026
    Report Date
    May 7, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER: UNKNOWN / NOT PROVIDED. A2: AGE AT TIME OF THE EVENT: UNKNOWN / NOT PROVIDED. A3: GENDER: UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION PMA/510(K) #: K011028/K013227.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107859 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1256202 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1