BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24568260 · Received March 11, 2026

    Report

    Report Number
    0001038806-2026-01293
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 2, 2026
    Report Date
    May 7, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    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). D10: CONCOMITANT MEDICAL PRODUCT: HXL1.25, TOOL HEX SST 1.25MM 22MM. HX1.25D, DRILL 1.25MM HEX SST. G4: PREMARKET IDENTIFICATION PMA/510(K) #: K011028/K013227.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT DIDN'T DISENGAGED THE MOUNT DURING THE CLINICAL PROCEEDING. A DRIVER FRACTURED TRYING TO SEPARATE THE MOUNT FROM THE IMPLANT AND ANOTHER BENT. IMPLANT WAS REMOVED. PROCEEDING WAS FULLY COMPLETED WITH ANOTHER DRIVER AND IMPLANT. THIS REPORT REFERS TO NOT DISENGAGING EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113355 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1284747 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1