BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24516927 · Received March 5, 2026

    Report

    Report Number
    0001038806-2026-01158
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    January 16, 2026
    Report Date
    April 24, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019560
    PMA / PMN Number
    K061410
    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). A2: AGE AT TIME OF THE EVENT: UNKNOWN / NOT PROVIDED. A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION PMA/510(K) #: K011028/K013227.

    Description of Event or Problem · 0

    THE DOCTOR REPORTS THAT THE IMPLANT CONTAINER ARRIVED EMPTY AND THE PROCEDURE WAS COMPLETED WITH THE PLACEMENT OF OTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107531 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1289379 00889024019560

    Patients

    Seq Age Sex Outcome Treatment
    1