BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AWL, SS

    MDR report key: 2474717 · Received March 1, 2012

    Report

    Report Number
    2027467-2012-00006
    Event Type
    Injury
    Date Received
    March 1, 2012
    Date of Event
    January 27, 2012
    Report Date
    February 3, 2012
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EVALUATION POSSIBLE. THE INSTRUMENT IN QUESTION HAS NOT BEEN RETURNED. UPON RECEIPT OF THE SUSPECT DEVICE AN EVALUATION WILL BE PERFORMED AND A FOLLOW UP REPORT WITH RESULTS OF THE INVESTIGATION PROVIDED.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE CANNOT BE DETERMINED. AN EVALUATION OF THE SUSPECT DEVICE FOUND NO MANUFACTURING, PROCESSING OR DESIGN RELATED IRREGULARITIES. TESTING CONFIRMED THE INSTRUMENT TO BE PROPERLY MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. THE FRAGMENT RETAINED BY THE PATIENT IS APPROXIMATELY .150 IN LENGTH WHICH HAS BEEN GROUND AT (B)(4) TO FORM A SHARP TROCAR TIP INTENDED TO PENETRATE CORTICAL BONE. THE DEVICE IS MANUFACTURED FROM A (B)(4).

    Description of Event or Problem · 1

    WHILE USING A CANNULATED AWL TO PREPARE THE PEDICLE REGION OF THE VERTEBRAE, ONE OF THE THREE POINTED TROCAR TIPS FRACTURED AND SEPARATED FROM THE INSTRUMENT. THE FRAGMENT WAS NOT REMOVED FROM THE PATIENT AND REMAINS ANCHORED IN THE SACRUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AWL, SS LXH LXH ALPHATEC SPINE INC 73711 5749202

    Patients

    Seq Age Sex Outcome Treatment
    1 Other