BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 25169305 · Received May 14, 2026

    Report

    Report Number
    0001038806-2026-02646
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    March 5, 2026
    Report Date
    May 14, 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
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT: UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION PMA/510(K) #: K011028/K013227.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE # 24 WAS REMOVED DUE TO A FRACTURE AT THE IMPLANT COLLAR. NO IMPACT ON THE PATIENT REPORTED. PROCEDURE WAS COMPLETED. BONE DENSITY TYPE: IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4308 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1235572 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1