BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STABILIZATION SCREW, 4.3MM DIA X 50MM LGTH

    MDR report key: 1005422 · Received February 29, 2008

    Report

    Report Number
    9612007-2008-00007
    Event Type
    Malfunction
    Date Received
    February 29, 2008
    Report Date
    February 29, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INCIDENT. CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORPORATION. 311 ENTERPRISE DRIVE. PLAINSBORO, NJ 08536. ATTN: CORPORATE COMPLAINT COORDINATOR

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS TRYING TO FUSE A JONES FRACTURE AND WHILE HE WAS PLACING THE QWIK SCREW, IT GOT STUCK DUE TO THE ANGLE OF THE K-WIRE. THE SCREW FIXATED THE FRACTURE BUT HALF OF THE SCREW WAS STICKING OUT OF THE BODY. THEY WERE GOING TO USE BOLT CUTTERS TO CUT THE SCREW AND LEAVE THE OTHER PART OF THE SCREW IN THE BODY; HOWEVER, WHEN THE PHYSICIAN TRIED BACKING THE SCREW OUT A LITTLE THE HEAD OF THE SCREW POPPED OFF. ONLY THE HEAD OF THE SCREW IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIZATION SCREW, 4.3MM DIA X 50MM LGTH NONE HWC INTEGRA NEUROSCIENCES IMPLANTS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR