BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM SELF-TAPPING, HEXALOBE SCREW, 14MM (TI-6AI-4V ELI)

    MDR report key: 6608036 · Received June 2, 2017

    Report

    Report Number
    2027467-2017-00044
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    October 25, 2016
    Report Date
    May 5, 2017
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K102820
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE A TOTAL OF FOUR (4) TRESTLE LUXE SCREWS CONTAINING TWO (2) SEPARATE IDENTIFYING NUMBERS UTILIZED IN THE CASE. BOTH ARE MANUFACTURED TO THE SAME LENGTH AND DIAMETER. THE DIFFERENCE BETWEEN THE TWO IS ONE IS A VARIABLE ANGLE & ONE FIXED ANGLE. IT IS UNKNOWN WHICH PART NUMBER/DESCRIPTION BELONGS TO THE TWO (2) FRACTURED/BROKEN SCREWS. THE 71340-14; 4.0 MM VARIABLE ANGLE, SELF-TAPPING HEXALOBE SCREW, 14 MM (TI-6AI-4V ELI), 71540-14; 4.0 MM FIXED ANGLE, SELF-TAPPING, HEXALOBE SCREW, 14 MM (TI-6AI-4V ELI). AN EVALUATION OF THE TRESTLE LUXE SCREWS IS NOT POSSIBLE AT THIS TIME. THE REMOVED IMPLANTS HAVE NOT BEEN RETURNED FOR EVALUATION NOR HAVE THE IDENTIFYING LOT NUMBER(S) BEEN PROVIDED.

    Description of Event or Problem · 1

    POST OP X-RAYS TAKEN ON (B)(6) 2016 FOUND BOTH TRESTLE LUXE SCREWS LOCATED AT THE C6 CERVICAL VERTEBRAE HAD FRACTURED AND BROKE. REVISION SURGERY WAS CONDUCTED ON (B)(6) 2016 TO REMOVE THE ENTIRE TRESTLE LUXE PLATING SYSTEM. THE PROXIMAL SECTIONS OF BOTH BROKEN SCREWS WERE SUCCESSFULLY REMOVED, WHILE THE DISTAL PORTIONS WERE LEFT IN PLACE AS THEY WERE NOT PROTRUDING ANTERIORLY AND POSITIONED DEEP DOWN WITHIN THE VERTEBRAL BODY. THE TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2015 DURING AN ANTERIOR CERVICAL DECOMPRESSION AND FUSION OF THE C6-C7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389078 4.0MM SELF-TAPPING, HEXALOBE SCREW, 14MM (TI-6AI-4V ELI) SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ ALPHATEC SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization