BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,10,MTX,MG

    MDR report key: 25260247 · Received May 22, 2026

    Report

    Report Number
    0001038806-2026-02852
    Event Type
    Injury
    Date Received
    May 22, 2026
    Date of Event
    May 7, 2026
    Report Date
    May 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). G4: ADDITIONAL PMA/510(K) NUMBER K101977. H6: ADDITIONAL H6- PATIENT CODES: 1690: ABSCESS, 4755: SWELLING/EDEMA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO INFECTION & BONE LOSS. IMPLANT BECOME LOOSE AND SWELLING- ANTIBIOTIC SUB. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS & PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405909 IMP,TSV,4.7,10,MTX,MG DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1295812 00889024019997

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Required Intervention