BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHIR ANTERIOR CERVICAL SYSTEM

    MDR report key: 3021653 · Received March 26, 2013

    Report

    Report Number
    1030489-2011-00917
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    May 17, 2011
    Report Date
    June 21, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K994239
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER FDA INVESTIGATION, THE SUBMISSION IN QUESTION BELOW CANNOT BE FOUND IN THE SYSTEM. THERE WAS A POSSIBILITY THAT IT DID NOT LOAD PROPERLY DURING SUBMISSION. IN ADDITION, SINCE THE SUBMISSION IS TOO OLD, THE ACK3 FILES (IF THERE WERE ANY) COULD NOT BE FOUND IN THE EMDR SYSTEM. (B)(4): 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 AN ANTERIOR CERVICAL SPINAL SURGERY AT C3-7. APPROXIMATELY 4 WEEKS POST-OP THE PATIENT FELL. AFTER THE FALL THE PATIENT COULD FEEL A LUMP IN THE THROAT AREA. THREE WEEKS LATER THE PATIENT WENT TO THE SURGEON AND FILMS WERE TAKEN WHICH SHOWED THAT THE SUPERIOR SCREW HAD COMPLETELY BACKED OUT OF THE PLATE. THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE SCREWS AND THE PLATE. ALL HARDWARE WAS REMOVED SUCCESSFULLY EXCEPT THE SCREW THAT HAD MIGRATED WITHIN THE CERVICAL AREA. THE MIGRATING SCREW WAS REMOVED WITH THE ASSISTANCE OF ANOTHER SURGEON THROUGH THE ESOPHAGUS. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124058 ZEPHIR ANTERIOR CERVICAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ WARSAW ORTHOPEDIC, INC. NA W07D2055

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATE, SCREW