BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW REMOVAL TOOL (STAINLESS STEEL)

    MDR report key: 4318189 · Received December 10, 2014

    Report

    Report Number
    2027467-2014-00045
    Event Type
    Injury
    Date Received
    December 10, 2014
    Date of Event
    November 24, 2014
    Report Date
    November 24, 2014
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE SUSPECT DEVICE AS WELL AS A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO ANOMALIES. THE INSTRUMENT WAS PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH DESIGN SPECIFICATIONS. TESTING SHOWED THE RAW MATERIAL OF THE INTERNAL SHAFT (51912-02-02) TO BE MANUFACTURED OUT OF 17-4SS PER ASTM A564 AND THE HARDNESS WAS MEASURED 41 HRC BOTH MEETING PRINT REQUIREMENTS. INSPECTION UNDER MAGNIFICATION REVEALED THE FRACTURE WAS A NON- TORSIONAL SHEAR FRACTURE LIKELY CAUSED BY LEVERAGE. THE FRAGMENT RETAINED BY THE PATIENT IS APPROXIMATELY .067" IN LENGTH AND IS ENTRAPPED WITHIN THE HEAD OF THE SCREW IMPLANTED AT THE S1.

    Description of Event or Problem · 1

    AFTER THE SCREWS HAD BEEN FULLY SEATED AND THE PLATE LOCKING MECHANISM RETURNED TO THE CLOSED POSITION, THE SURGEON NOTICED ONE OF THE SCREWS WAS POSITIONED CEPHALAD ALONG THE S1. HE WANTED TO PLACE IT A LITTLE MORE CAUDAL. THE SCREW REMOVAL TOOL WAS ENGAGED INTO HEAD OF THE DESIRED SCREW BUT COULD NOT BE ROTATED. PLIERS WERE ATTACHED TO THE KNOB IN AN ATTEMPT TO OBTAIN ADDITIONAL ROTATIONAL FORCE. THE SCREW STILL COULD NOT BE REMOVED OR LOOSENED. IT WAS THEN NOTICED THAT THE DISTAL THREADED SECTION OF THE SCREW REMOVAL TOOL HAD FRACTURED AND BECAME SEPARATED FROM THE INSTRUMENT. IT REMAINS ENTRAPPED WITHIN THE SCREW LOCATED AT THE S1. A PATCH (HYDRO-SIX) WAS PLACED OVER THE CONSTRUCT TO ENSURE THE DETACHED TIP WILL NOT MIGRATE/COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800209 SCREW REMOVAL TOOL (STAINLESS STEEL) LXH LXH ALPHATEC SPINE INC 51912 6232102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other