BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRESTLE LUXE CERVICAL PLATE

    MDR report key: 5084768 · Received September 14, 2015

    Report

    Report Number
    MW5056207
    Event Type
    Injury
    Date Received
    September 14, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 14, 2015
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    0

    Narratives

    Description of Event or Problem · 1

    C4/C7 CERVICAL FUSION ON (B)(6) 2014 WITH USE OF TRESTLE LUXE ALPHA TEC SPINE PRODUCT. (B)(6) OF 2015 FOUND OUT THAT ALONG WITH NON-UNION OF C4/C5 AND C6/C7 THAT 2 SCREWS AT C4 LEVEL, 2 SCREWS AT C7 LEVEL WERE BROKEN. REVISION SURGERY ON (B)(6) 2015 REMOVAL OF BENT PLATE AND PARTIAL REMOVAL OF BROKEN SCREWS. FOUR SCREW TIPS ARE STILL IMBEDDED IN C4/C7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605893 TRESTLE LUXE CERVICAL PLATE TRESTLE LUXE CERVICAL PLATE KWQ ALPHATEC SPINE INC 71003-057

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization