BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD WISHBONE ASSEMBLY

    MDR report key: 6821045 · Received August 25, 2017

    Report

    Report Number
    2125289-2017-00012
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    July 24, 2017
    Report Date
    July 26, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FFO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 8/28/2017 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - THE DEVICE HAS BEEN CHECKED AND NO FAULT FOUND WITH THE DEVICE. DEVICE HISTORY EVALUATION - DEVICE HISTORY RECORD SHOWS A TOTAL OF (B)(4) WERE PRODUCED OF THIS LOT IN 2015. THE DEVICES MANUFACTURED DURING THIS PERIOD PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK, SEE BELOW. NO SERVICE HISTORY IS ON FILE FOR THIS DEVICE. CONCLUSION: FAILURE ANALYSIS BY (B)(4) REPAIR DEPOT WAS UNABLE TO CONFIRM COMPLAINT EVENT. DEVICE WAS FUNCTIONALLY TESTED AND NO FAULT FOUND WITH THE DEVICE.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS OMNI DEVICES NOT HOLDING. NO INJURY TO THE PATIENT ANY OTHER PATIENT INFORMATION UNKNOWN. TWO OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601338 STANDARD WISHBONE ASSEMBLY SURGICAL RETRACTOR FFO INTEGRA LIFESCIENCES CORPORATION OH/USA 159

    Patients

    Seq Age Sex Outcome Treatment
    1