BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3355088 · Received September 18, 2013

    Report

    Report Number
    1030489-2013-03931
    Event Type
    Injury
    Date Received
    September 18, 2013
    Date of Event
    August 20, 2013
    Report Date
    August 20, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7752536, 510K # K082728 WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR CERVICAL SPINAL FUSION AT C5-7 TO TREAT A C5 SUBLUXATION. IT WAS REPORTED THAT WHILE PLACING THE CROSSLINK ON THE RODS, THE CROSSLINK TOUCHED THE SPINAL CORD. IMMEDIATELY POST-OP THE PATIENT PRESENTED WITH MUSCLE WEAKNESS AND THE PATIENT¿S LEGS WERE PARALYZED. 5 DAYS POST-OP THE PATIENT LEGS WERE ABLE TO MOVE BUT IT IS UNKNOWN AT THIS TIME IF THE PATIENT WILL BE ABLE TO WALK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471212 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0230549W

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Disability