BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK/L GENERIC

    MDR report key: 3118394 · Received May 14, 2013

    Report

    Report Number
    2184052-2013-00020
    Event Type
    Injury
    Date Received
    May 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    ZIMMER SPINE
    Product Code
    MAX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. WHILE THE CAUSE FOR THE NON-FUSION IS UNKNOWN, IT IS NOTED IN THE CLINICAL RESULTS SECTION OF THE IFU THAT THE FUSION RATE IS NOT 100%. THIS IS THE FINAL REPORT THAT WILL BE SUBMITTED ASSOCIATED WITH THIS INCIDENT AND DEVICE. NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT REMOVAL OF BAK/ L IMPLANT DUE TO NON-UNION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212847 BAK/L GENERIC BAK/L GENERIC MAX ZIMMER SPINE BAK/L GENERIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R