BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 16MM

    MDR report key: 20619693 · Received November 6, 2024

    Report

    Report Number
    0002023141-2024-03519
    Event Type
    Injury
    Date Received
    November 6, 2024
    Report Date
    November 5, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020122
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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: PMA/510(K) NUMBER K061410, K011028, K013227. 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. H3 OTHER TEXT: SUMMARY INVESTIGATION

    Description of Event or Problem · 0

    IT WAS REPORTED #7 AND 10 WERE INFECTED DUE TO MASSIVE DEFECT. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NOT INDICATED. ADDITIONAL APPOINTMENT REQUIRED: NOT INDICATED. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998456 IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 16MM DENTAL IMPLANT DZE ZIMMER DENTAL 1277180 00889024020122

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention TSV4H13