BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACFIX TI 5.5MM WEDGE NON-THREADED

    MDR report key: 1192115 · Received October 7, 2008

    Report

    Report Number
    1649384-2008-00507
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 12, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ABBOTT SPINE
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MFR DATE MAY ALSO BE 6/2003. REVIEW OF THE DEVICE HISTORY RECORDS FOUND THE PART MET SPECIFICATIONS. VISUAL EXAMINATION INDICATES A DEFORMITY ON THE LOCKING FEATURE OF THE TAB. THE INVESTIGATION DETERMINED THE MOST LIKELY CAUSE TO BE USE ERROR BASED ON THE VISUAL EVIDENCE.

    Description of Event or Problem · 1

    IN 2008, THE SALES REP REPORTED THAT DURING SURGERY THE WEDGE WOULD NOT SEAT INTO THE SCREW PROPERLY. ADDITIONAL INFO RECEIVED ON 24 SEP 2008 VIA TELEPHONE. THE SALES REP REPORTED THAT DURING A REVISION SURGERY, THE SURGEON WAS EXTENDING THE CONSTRUCT FOR ADJACENT LEVELS. THE ORIGINAL CONSTRUCT HAD 6.0 RODS AND THE KIT THAT WAS OPENED FOR SURGERY WAS FOR 5.0 RODS, SO THE SURGEON EXPLANTED THE WEDGES AND REPLACED THEM WITH NEW ONES, SO THE SURGEON WOULD NOT HAVE TO EXPLANT THE SCREWS. DURING THIS PROCESS, THE SURGEON NOTICED THAT ONE OF THE WEDGES WOULD NOT SEAT THE SCREW PROPERLY. THE SURGEON FINISHED THE CASE BY IMPLANTING ANOTHER WEDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACFIX TI 5.5MM WEDGE NON-THREADED BACFIX KWP ABBOTT SPINE 15KH OR 15KF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention