BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1/4" SQUARE 4MM DRIVER

    MDR report key: 3894184 · Received February 6, 2014

    Report

    Report Number
    2032593-2014-00004
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Report Date
    January 8, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    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. PURSUANT TO 21 CFR 803.24 NEITHER THE FILLING OF THIS MEDICAL DEVICE REPORT NOR THE INFORMATION CONTAINED HEREIN SHALL BE CONSTRUED AS AN ADMISSION OR ACKNOWLEDGEMENT THAT THE INFORMATION SUBMITTED TO INTEGRA LIFESCIENCES HOLDING CORPORATION OR ANY OF ITS SUBSIDIARIES IS VALID OR THAT THE DEVICE CAUSED OR CONTRIBUTED IN ANY WAY TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE LOCKING CAP TIGHTENER (1/4" SQUARE 4MM DRIVER) BROKE DURING THE LOCKING STEP OF SURGERY." (B)(6) 2014: ADDITIONAL INFORMATION WAS RECEIVED. THE TIP BROKE; IT STAYED INSIDE LOCKING CAP. A SPARE DEVICE WAS AVAILABLE THAT FUNCTIONED PROPERLY. THERE WAS NO DELAY IN SURGERY; NO INJURY OR ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BY INTEGRA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78424 1/4" SQUARE 4MM DRIVER DAYTONA KWQ SEASPINE, INC. AU3364601A

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR