BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,11.5,MTX,MG

    MDR report key: 25160172 · Received May 13, 2026

    Report

    Report Number
    0001038806-2026-02637
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Report Date
    May 13, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER OPENED THE IMPLANT PACKAGE TO FIND NO IMPLANT IN THE BOX. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302475 IMP,TSV,4.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1258716 00889024020009

    Patients

    Seq Age Sex Outcome Treatment
    1