BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,6.0,10,MTX,MG

    MDR report key: 25019622 · Received April 28, 2026

    Report

    Report Number
    0001038806-2026-02349
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    April 20, 2026
    Report Date
    April 28, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019874
    PMA / PMN Number
    K101977/
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 #3 WAS REMOVED DUE TO BONE LOSS. PATIENT CAME IN FOR AN IMPLANT REPAIR, DOCTOR NOTICED TOO MUCH BONE LOSS AROUND IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080742 IMP,TSV,6.0,10,MTX,MG DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1243449 00889024019874

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention