BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM

    MDR report key: 20619706 · Received November 6, 2024

    Report

    Report Number
    0002023141-2024-03521
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    August 1, 2024
    Report Date
    November 5, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019584
    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). A2: DATE OF BIRTH UNKNOWN / NOT PROVIDED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PATIENT RETURNED WITH IMPLANT IN HAND. TOOTH NUMBER 12. PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NOT INDICATED. ADDITIONAL APPOINTMENT REQUIRED: YES, DEBRIDEMENT AND BONE GRAFT. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999448 IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL 1271873 00889024019584

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention