BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP, TSV, 4.7, 8, MTXF, MG, HA

    MDR report key: 25302202 · Received May 27, 2026

    Report

    Report Number
    0001038806-2026-02928
    Event Type
    Injury
    Date Received
    May 27, 2026
    Date of Event
    May 2, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024344389
    PMA / PMN Number
    K101880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN/NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K133339 CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMVIE FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE PLACING THE IMPLANTS AT TOOTH SITES #30 AND #31, WHEN PLACING THE HEALING ABUTMENT, THE IMPLANTS WENT PAST THE CORTICAL PLATE CAUSING NERVE DAMAGE. THE IMPLANTS WERE REMOVED AND THE PATIENT NO LONGER WANTS IMPLANTS. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION AND PARASTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614114 IMP, TSV, 4.7, 8, MTXF, MG, HA DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1268177 00889024344389

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention