BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,11.5,MTX,MG

    MDR report key: 25104669 · Received May 6, 2026

    Report

    Report Number
    0001038806-2026-02476
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Report Date
    May 6, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024020009
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A1: PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. A2: AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. A3: PATIENT SEX UNKNOWN / NOT PROVIDED. A4: WEIGHT UNKNOWN / NOT PROVIDED. B3: DATE OF EVENT UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K101880. 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 THE DOCTOR WENT TO OPEN AN IMPLANT DURING A PROCEDURE AND THE IMPLANT PACKAGE WAS EMPTY. THE INNER VIAL WAS INSIDE BUT EMPTY. THEY WERE ABLE TO COMPLETE THE PROCEDURE WITH ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78951 IMP,TSV,4.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1258716 00889024020009

    Patients

    Seq Age Sex Outcome Treatment
    1