BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP TM 4.7MM MTX FULL, 10

    MDR report key: 24965104 · Received April 23, 2026

    Report

    Report Number
    0001038806-2026-02226
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    January 18, 2026
    Report Date
    April 23, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019034
    PMA / PMN Number
    K132258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. E1: LAST NAME UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER K113753, K112160.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO BONE LOSS, SITE 13. PATIENT CAME IN TO GET ABUTMENT PLACED. INSUFFICIENT BONE/STABILITY FOUND AROUND IMPLANT. PATIENT WILL HAVE IMPLANT REPLACED. SITE GRAFTED WITH IMPLANT PLACEMENT. NOTED INFLAMMATION AND EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180734 IMP TM 4.7MM MTX FULL, 10 DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1298817 00889024019034

    Patients

    Seq Age Sex Outcome Treatment
    1