BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD WISHBONE ASSEMBLY

    MDR report key: 6501592 · Received April 18, 2017

    Report

    Report Number
    2125289-2017-00007
    Event Type
    Malfunction
    Date Received
    April 18, 2017
    Date of Event
    February 13, 2017
    Report Date
    March 23, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FFO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ON 05/02/17 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - THE DEVICE WAS NOT RELEASED FOR EVALUATION THEREFORE FAILURE ANALYSIS COULD NOT BE DETERMINED. DEVICE HISTORY EVALUATION - A DHR REVIEW CANNOT BE PERFORMED AT THIS TIME AS THE LOT NUMBER AS PROVIDED IS NOT TRACEABLE. CONCLUSION: THE DEVICE WAS NOT RELEASED FOR EVALUATION THEREFORE THE ROOT CAUSE TO THE END USERS EXPERIENCE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE REOPENED SHOULD WE RECEIVE PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS THE ARMS ARE NOT HOLDING INTO PLACE WHEN LOCKED DOWN. ON (B)(6) 2017 CUSTOMER REPORTS THE EVENT OCCURRED DURING AN INTRALUMBAR INTERBODY FUSION. THEY NOTICED WHEN PLACING THE DEVICE THAT IT WASN'T GOING TO HOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282137 STANDARD WISHBONE ASSEMBLY SURGICAL RETRACTOR FFO INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1