BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 25114131 · Received May 7, 2026

    Report

    Report Number
    0001038806-2026-02509
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    April 2, 2026
    Report Date
    May 7, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(6). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. E1: LAST NAME UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER K011028, K013227.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO INFECTION. DISCOVERED DURING CLINICAL PROCEDURE. FAILED IMPLANT @ STAGE 2. SYMPTOMS / PATIENT IMPACT: INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467630 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1289102 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1