BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP, TSV, 4.7, 10, MTXF, MG,HA

    MDR report key: 20506668 · Received October 22, 2024

    Report

    Report Number
    0002023141-2024-03356
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    June 12, 2024
    Report Date
    October 21, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344341
    PMA / PMN Number
    K101880
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). A4: WEIGHT UNKNOWN / NOT PROVIDED. E1: LAST/GIVEN NAME UNKNOWN / NOT PROVIDED. G4: ADDITIONAL PMA/510(K) NUMBER ¿ K133339. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR INFECTION EVENTS IDENTIFYING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO THE WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED) FACTORS POTENTIALLY IMPACTING THE STERILITY OF THE IMPLANT AND ITS ENVIRONMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD ACUTE IMPLANT FAILURE AROUND THE IMPLANT AT TOOTH LOCATION #19 DUE TO INFECTION. THE IMPLANT WAS REMOVED. SYMPTOMS AS A RESULT OF THE EVENT: EDEMA, PAIN AND INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946893 IMP, TSV, 4.7, 10, MTXF, MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL 1264495 00889024344341

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention