BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM

    MDR report key: 9402162 · Received December 3, 2019

    Report

    Report Number
    2027467-2019-00056
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    August 29, 2017
    Report Date
    November 4, 2019
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    PMA / PMN Number
    K102820
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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. 71340-14; 4.0 MM VARIABLE ANGLE, SELF-TAPPING HEXALOBE SCREW, 14 MM (TI-6AI-4V ELI) - UDI# ((B)(4). 71540-14; 4.0 MM FIXED ANGLE, SELF-TAPPING, HEXALOBE SCREW, 14 MM (TI-6AI-4V ELI) - UDI# (B)(4). AN EVALUATION OF THE TRESTLE LUXE SCREWS IS NOT POSSIBLE AT THIS TIME. IT IS UNKNOWN WHETHER THE ALLEGED DEFECTIVE ANCHORS HAVE BEEN REMOVED FROM THE PATIENT. NO OTHER INFORMATION OR CORRESPONDENCE HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    ALPHATEC VP, ASSOCIATE GENERAL COUNSEL RECEIVED A PRODUCT LIABILITY CLAIM ON (B)(6) 2019. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017 IT WAS DISCOVERED TWO FIXATION SCREWS OF AN ALPHATEC TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM HAD FRACTURED AND BROKE. THE TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM WAS ORIGINALLY IMPLANTED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202166 TRESTLE LUXE ANTERIOR CERVICAL PLATING SYSTEM SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ ALPHATEC SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other