BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    MDR report key: 16245758 · Received January 26, 2023

    Report

    Report Number
    0002023141-2023-00315
    Event Type
    Injury
    Date Received
    January 26, 2023
    Date of Event
    November 21, 2022
    Report Date
    May 9, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020047
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1230954). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1230954) FOR SIMILAR EVENTS AND ONE OTHER COMPLAINT WAS IDENTIFIED. INVESTIGATION HAS IDENTIFIED THAT THE MOST LIKELY PROBABLE CAUSES ARE RELATED TO MEDICAL CONDITIONS/PATIENT HABITS AND SURGICAL TECHNIQUE. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR BONE LOSS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR BONE LOSS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT NUMBER (B)(4). PMA/510(K) NUMBER: K011028 AND K013227.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO BONE LOSS AROUND THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109844 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB10 1230954 00889024020047

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention