BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALIF AWL STRAIGHT

    MDR report key: 3964737 · Received June 20, 2014

    Report

    Report Number
    3005180920-2014-00077
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Manufacturer
    MEDACTA INTERNATIONAL, SA
    Product Code
    LXH
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE DOCUMENT REVIEW OF THE LOT INVOLVED (1214296 - (B)(4) ITEMS PRODUCED) NO ANOMALIES WERE FOUND. FROM THE LATERAL X-RAY - ANALYSIS PERFORMED BY THE R&D SPINE DIRECTOR - IT IS VISIBLE THAT THE INSERTION ANGLE OF THE AWL DOES NOT OVERLAP WITH THE INSERTION ANGLE OF THE SCREW. THEREFORE WE CAN ASSUME THAT THE SURGEON DID NOT USE THE DRILL SLEEVE TO GUIDE THE AWL AS DESCRIBED IN THE SURGICAL TECHNIQUE. THE COMBINATION OF NOT USING THE DRILL SLEEVE AND A POTENTIALLY HIGH LATERAL FORCE (POTENTIAL DIFFICULT ANATOMY/PUBLIC SYMPHYSIS) APPLIED ON THE AWL RESULTED IN THE INSTRUMENT BREAKAGE.

    Description of Event or Problem · 1

    IMPORTER REPORT #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363419 ALIF AWL STRAIGHT REUSABLE SURGICAL INSTRUMENT FOR SPINE LXH MEDACTA INTERNATIONAL, SA

    Patients

    Seq Age Sex Outcome Treatment
    1