BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24615163 · Received March 17, 2026

    Report

    Report Number
    0001038806-2026-01430
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 4, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019515
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4) A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K013227.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MOUNT COULDN'T BE REMOVED FROM THE IMPLANT AT TOOTH SITE #25. DOCTOR HAD TO PROCEED WITH ANOTHER IMPLANT. NO IMPACT ON THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516600 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1298475 00889024019515

    Patients

    Seq Age Sex Outcome Treatment
    1