BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDEWIRE

    MDR report key: 2405291 · Received January 9, 2012

    Report

    Report Number
    2027467-2011-00037
    Event Type
    Injury
    Date Received
    January 9, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 22, 2011
    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

    NO EVALUATION POSSIBLE. THE SEPARATED DISTAL TIP OF THE GUIDE WIRE REMAINS CAPTURED WITHIN THE PATIENTS S1 VERTEBRAE. THE REMAINDER WAS INADVERTENTLY DISCARDED BY THE USER FACILITY. THE IDENTIFYING LOT NUMBER HAS NOT BEEN PROVIDED. GUIDEWIRES ARE INTENDED TO MAINTAIN POSITION OF THE ENTRY POINT WHILE ADDITIONAL CANNULATED INSTRUMENTATION (AWL, DRILLS ETC.) ARE INSERTED/REMOVED IN ORDER TO PREPARE THE PEDICLE FOR THE SCREW TO BE IMPLANTED. DURING PLACEMENT, IT IS RECOMMENDED TO FREQUENTLY USE ALTERNATE IMAGING PLANES. IDEALLY, AN A-P, LATERAL, AND OBLIQUE VIEW SHOULD BE TAKEN AT ALL CRITICAL STEPS DURING THE PROCEDURE TO ENSURE PROPER POSITIONING AND ALIGNMENT, AND TO PREVENT KINKING OR BREAKAGE OF THE DEVICES. THE DEVICE IS NOT DESIGNED TO BE USED IN CONJUNCTION WITH A POWERED DRIVER. THE DEVICE IN QUESTION IS MANUFACTURED OUT OF 316 LVM STAINLESS STEEL CERTIFIED TO ASTM F138 WHICH SIGNIFIES IT AS AN IMPLANTABLE GRADE OF STAINLESS.

    Description of Event or Problem · 1

    THE DISTAL TIP OF A STAINLESS STEEL GUIDE WIRE FRACTURED AND SEPARATED DURING A MIS CASE ON (B)(6) 2011. THE INSTRUMENT WAS INTRODUCED TO THE SITE THROUGH A CANNULATED TARGETING NEEDLE WITHOUT ISSUE. IT WAS THEN REPOSITIONED AND ATTACHED TO A POWERED DRIVER. ONCE ACTIVATED, THE GUIDE WIRE BROKE LEAVING DISTAL TIP LODGED WITHIN THE PATIENTS S1 VERTEBRAE AND ALSO PROTRUDING INTO THE DISK SPACE. THERE ARE NO PLANS TO REMOVE FOREIGN BODY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDEWIRE ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH ALPHATEC SPINE INC 73703

    Patients

    Seq Age Sex Outcome Treatment
    1 Other