BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

    MDR report key: 24828736 · Received April 9, 2026

    Report

    Report Number
    0001038806-2026-01897
    Event Type
    Malfunction
    Date Received
    April 9, 2026
    Date of Event
    February 4, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024020085
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: PREMARKET IDENTIFICATION PMA/510(K) #: K011028/K013227.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    DOCTOR REPORTS AFTER PLACING THE IMPLANT AT TOOTH SITE 36, IT DID NOT OBTAIN PRIMARY STABILITY AND ALSO THEY COULD NOT DISENGAGE THE MOUNT. THEY COULD FINALLY FORCIBLY REMOVE IT AND PLACED ANOTHER IMPLANT OF THE SAME TYPE IN POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183376 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1293767 00889024020085

    Patients

    Seq Age Sex Outcome Treatment
    1