BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIX-C GUIDED ANGLE AWL

    MDR report key: 5012280 · Received August 18, 2015

    Report

    Report Number
    3005031160-2015-00009
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    July 15, 2015
    Report Date
    August 14, 2015
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    HWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION. CANNOT BE RELIABLY DETERMINED, DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE WAS NOT RETUNED FOR EVALUATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE TIP OF THE GUIDED ANGLE AWL FORM THE IRIX-C SYSTEM BROKE OFF DURING SURGERY ON (B)(6) 2015. THE REPRESENTATIVE AND COMPLAINANT FROM BACKBONE MEDICAL REPORTED THAT THERE WAS NO DELAY IN SURGICAL TIME AND THERE WAS NO INJURY TO THE PATIENT. IF THE AWL IS RECEIVED BACK FOR INVESTIGATION OR ANY FURTHER INFORMATION IS RECEIVED THIS REPORT WILL BE AMENDED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545277 IRIX-C GUIDED ANGLE AWL AWL HWJ X-SPINE SYSTEMS, INC. T066-0205

    Patients

    Seq Age Sex Outcome Treatment
    1