BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 24952623 · Received April 22, 2026

    Report

    Report Number
    0001038806-2026-02194
    Event Type
    Injury
    Date Received
    April 22, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 22, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019997
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. G4: ADDITIONAL PMA/510(K) NUMBER K101880.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE # 31 WAS REMOVED DUE TO BONE LOSS. LOOSE IMPLANT, BONE LOSS. PATIENT WILL RETURN FOR IMPLANT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323491 IMP,TSV,4.7,10,MTX,MG DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1257016 00889024019997

    Patients

    Seq Age Sex Outcome Treatment
    1