BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 11.5MM

    MDR report key: 20555669 · Received October 29, 2024

    Report

    Report Number
    0002023141-2024-03445
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    August 15, 2024
    Report Date
    October 29, 2024
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020108
    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). G4: PMA/510(K) NUMBER: K061410/ 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 AT TIME OF HEALING COLLAR PLACEMENT IMPLANT WAS MOBILE WITH INFLAMMATION TISSUE AROUND IT. HEALING COLLAR PLACED (B)(6) 2023 AND TEEHA455 PLACED (B)(6) 2023. ON (B)(6) 2024, DENTIST FELT AREA WAS INFECTED, PLACED ON ANTIBIOTICS. THIS EVENT IS GOING TO BE REPORTED UNDER (B)(4). PER INDICATED: SURGICAL/MEDICAL INTERVENTION REQUIRED FOR PERMANENT DAMAGE: NO. ADDITIONAL APPOINTMENT REQUIRED: NO. SYMPTOMS AS A RESULT OF THE EVENT: NONE. WAS THE PROCEDURE COMPLETED USING ANOTHER IMPLANT OR ANOTHER DEVICE: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928741 IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 1256313 00889024020108

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention TEEHA455 AND HEALING COLLAR