BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LXH

    MDR report key: 5071693 · Received September 11, 2015

    Report

    Report Number
    2027467-2015-00184
    Event Type
    Injury
    Date Received
    September 11, 2015
    Date of Event
    June 17, 2015
    Report Date
    September 11, 2015
    Manufacturer
    TECOMET
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RECEIVED NOTIFICATION ON (B)(4) 2015 THAT THE MANUFACTURER TECOMET DOES NOT FEEL THAT THIS COMPLAINT WARRANTS A SUBMISSION UNDER THE CURRENT FDA GUIDELINES, THEREFORE WILL NOT BE SUBMITTING AN MDR. (B)(4) ASSESSMENT OF THE EVENT HAS DETERMINED THAT A MEDICAL DEVICE REPORT SHOULD BE FILED FOR THIS OCCURRENCE AND WILL DO SO ON TECOMET'S BEHALF.

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS RETURNED TO ALPHATEC ON 9/22/2015. ALPHATEC THEN SHIPPED THE INSTRUMENT TO THE MANUFACTURER (TECOMET) ON 9/25/2015 FOR EVALUATION. ON 9/25/2015 TECOMET (MANUFACTURER) PROVIDED INVESTIGATION ID# (B)(4) WHICH DETERMINED ROOT CAUSE TO BE OVER-TORQUE OR OFF-AXIS LOADING OF THE DEVICE.

    Description of Event or Problem · 1

    WHILE PLACING A SCREW INTO THE PT'S LUMBER AREA OF THE BACK DURING THE PROCEDURE, THE END OF THE SCREWDRIVER BIT BROKE OFF INTO THE SCREW THAT WAS PLACED IN THE PT. SURGEON WAS UNABLE TO OBTAIN THE BROKEN PIECE. (B)(4) SCREW 3.0MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601913 LXH LXH TECOMET HD2061181 621479C10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other