BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 16MM

    MDR report key: 24827799 · Received April 9, 2026

    Report

    Report Number
    0001038806-2026-01895
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    October 22, 2025
    Report Date
    May 22, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019539
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). . D10. CONCOMITANT MEDICAL PRODUCTS TSVWB11, IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 11.5MM LOT 1290012 G4: PREMARKET IDENTIFICATION K011028/K013227.

    Description of Event or Problem · 0

    IT WAS REPORTED THE IMPLANTS WERE REMOVED FROM TOOTH SITE # (B)(6), DUE TO OVER-PRESSURE PAIN. PATIENT SUFFERED SORENESS, PAIN AND DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543513 IMPL TAPERED SCR-V SBM 3. 7MM 3.5MM 16MM DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1296050 00889024019539

    Patients

    Seq Age Sex Outcome Treatment
    1