BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,MCOL MG,4.7MM,11.5MML

    MDR report key: 24905319 · Received April 16, 2026

    Report

    Report Number
    0001038806-2026-02093
    Event Type
    Injury
    Date Received
    April 16, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ZIMVIE US CORP LLC
    Product Code
    DZE
    UDI-DI
    00889024019782
    PMA / PMN Number
    K111889
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 K101880.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMPLANT WAS REMOVED DUE TO FRACTURED IMPLANT COLLAR. TOOTH NUMBER: 30. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204828 IMP,TSV,MCOL MG,4.7MM,11.5MML DENTAL IMPLANT DZE ZIMVIE US CORP LLC 1221532 00889024019782

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown Required Intervention