BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZODIAC POLYAXIAL SCREW SYSTEM

    MDR report key: 903276 · Received August 22, 2007

    Report

    Report Number
    2027467-2007-00011
    Event Type
    Other
    Date Received
    August 22, 2007
    Date of Event
    May 17, 2007
    Report Date
    August 21, 2007
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K033090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF INFO PROVIDED BY THE INITIAL REPORTER WAS CONDUCTED. BASED ON THE DEPT. OF HEALTH AND HUMAN SERVICES INTERNET WEBSITE, THE PATIENT'S BODY MASS INDEX INDICATES THE PATIENT IS OVERWEIGHT AND COULD BE CONSIDERED OBESE. THE PACKAGE INSERT STATES: CONTRAINDICATION: PATIENTS WITH INFECTION, INFLAMMATION, FEVER, TUMORS, ELEVATED WHITE BLOOD CELL COUNT, OBESITY, PREGNANCY, MENTAL ILLNESS AND OTHER MEDICAL CONDITIONS, WHICH WOULD PROHIBIT BENEFICIAL SURGICAL OUTCOME. ADVERSE EFFECTS: THE FOLLOWING COMPLICATIONS AND ADVERSE REACTIONS HAVE BEEN SHOWN TO OCCUR WITH THE USE OF A SIMILAR SPINAL INSTRUMENTATION. THESE EFFECTS AND ANY OTHER KNOWN BY THE SURGEON MUST BE DISCUSSED WITH THE PATIENT PREOPERATIVELY. BONE GRAFT, VERTEBRAL BODY AND/OR SACRAL FRACTURE, AND/OR DISCONTINUED GROWTH OF FUSED BONE AT, ABOVE AND/OR BELOW THE SURGERY LEVEL. REVISION SURGERY. BASED ON THE CONTRAINDICATION, THE CAUSE OF THE INCIDENT IS RELATED TO THE USE OF THE DEVICE. BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER, THERE IS NO REPORTED MALFUNCTION OF THE DEVICE.

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO GET UP, PATIENT EXPERIENCED PAIN AND A POPPING SENSATION. X-RAYS SHOW THAT THE PATIENT'S PEDICLE AT L3 IS FRACTURED. THE MEDICAL DEVICE CONSTRUCT IS INTACT. THE PART INDICATED BY THE INITIAL REPORTED IS NOT BROKEN, NOR HAS IT MALFUNCTIONED. PATIENT UNDERWENT A REVISION SURGERY TO CORRECT THE PROBLEM IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZODIAC POLYAXIAL SCREW SYSTEM ZODIAC PEDICLE SCREW SYSTEM KWP ALPHATEC SPINE, INC. 82175-35 608645

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention