BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRESTLE ANTERIOR CERVICAL PLATING SYSTEM

    MDR report key: 1120873 · Received August 15, 2008

    Report

    Report Number
    2027467-2008-00014
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    December 4, 2007
    Report Date
    August 15, 2008
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    JDN
    PMA / PMN Number
    K070681
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT PRESENTED FOR A LEVEL ONE CERVICAL FUSION COMPLAINING OF HEADACHES IN 2008. X-RAYS WERE TAKEN WHICH SHOWED GOOD ALIGNMENT OF INSTRUMENTATION. THE PT RE-PRESENTED ABOUT 5 MONTHS LATER, COMPLAINING OF HEADACHES. X-RAYS WERE TAKEN WHICH REVEALED A FIXATION FAILURE AT LEVEL FIVE AND SIX MID AXILLARY. THE SALES REP CONFIRMED THE PT IS YOUNG AND IN EXCELLENT PHYSICAL CONDITION WITH NO RESULTING TRAUMA. HE CONFIRMED THE REVISION SURGERY WAS SCHEDULED FOR FEW DAYS LATER. THE RESULTS OF THE REVISION SURGERY HAVE NOT BEEN REC'D TO DATE. THE PT HAS REQUESTED THAT X-RAYS, DEVICES AND DETAILS OF THE REVISION SURGERY NOT BE PROVIDED TO THE MFR. THUS, AN EVAL OF THE MFG RECORDS AND PT RADIOGRAPHS CANNOT BE CONDUCTED. THE STATUS OF THE PT IS UNK.

    Description of Event or Problem · 1

    A FIXATION FAILURE AT LEVEL FIVE AND SIX MID-AXILLARY WAS DISCOVERED IN 2008. THE FAILURE WAS DETECTED ON AN X-RAY AT A F/U VISIT. THE DATE WHEN THE STRUCTURAL FAILURE OCCURRED IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRESTLE ANTERIOR CERVICAL PLATING SYSTEM CERVICAL PLATE, LEVEL 1 JDN ALPHATEC SPINE, INC. TBD TBD

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention