BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIONEER ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1210504 · Received October 21, 2008

    Report

    Report Number
    1833824-2008-00007
    Event Type
    Injury
    Date Received
    October 21, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 21, 2008
    Manufacturer
    PIONEER SURGICAL
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FILMS SHOW THAT THE PLATE WAS OVERSIZED AND WAS OVERLAPPING THE SUPERIOR VERTEBRAE BEYOND THE PLATE CONSTRUCT. THESE FILMS ALSO SHOW EXTREME SUBSIDENCE AND POSSIBLE PSEUDOARTHROSIS AT ALL THREE LEVELS, AND THAT THE SURGEON USED ONLY ONE SCREW IN EACH OF THE MIDDLE VERTEBRAES. THIS PLATE WAS DESIGNED TO BE USED WITH TWO SCREW PLACEMENT IN EACH VERTEBRAL BODY. THE IMPLANTS WERE NOT RETURNED FOR EVAL, AND NO MORE INFO IS AVAILABLE. (SEE SCANNED PAGES).

    Description of Event or Problem · 1

    APPROX 6 MONTHS POST OP THE PT CAME IN EXPERIENCING PAIN IN HER NECK. THROUGH X-RAYS IT WAS DETERMINED THAT THE BOTTOM SCREWS ON THE 3 LEVEL ANTERIOR CERVICAL CONSTRUCT WERE BROKEN. THE PLATE WAS REMOVED AND ACCORDING TO THE SURGEON THE PT HAS GONE ON TO FUSION. IN 2008: THREE LEVEL CERVICAL PLATE CONSTRUCT WAS IMPLANTED INTO THE PT FROM C4-C7. IN '08: PIONEER WAS NOTIFIED THAT THE PT HAD COME IN WHITH PAIN IN HER NECK AND THROUGH FILMS IT WAS DETERMINED THAT THE BOTTOM SCREWS HAD BROKEN. IN 2006: THE PLATE CONSTRUCT WAS REMOVED, AND THE SURGEON DID NOT REPLACE THE PLATE DUE TO HIS BELIEF THAT THE PT HAD GONE ONTO FUSION. IN 2008: PIONEER REQUESTED MORE INFO. PIONEER RECEIVED X-RAYS, AND AFTER REVIEW WITH THE CLINICAL ADVISOR DETERMINED THAT THE PLATE WAS OVERLAPPING C3 AND WAS THUS OVERSIZED. ALSO THE X-RAYS REVEALED THAT THE SURGEON HAD NOT APPLIED ALL THE SCREWS AS DESIGNED, LEAVING TWO SCREWS OUT OF THE CONSTRUCT IN THE MIDDLE. ALSO THERE WAS DETERMINED TO BE GREAT SUBSIDENCE AT ALL LEVELS AND POTENTIAL PSEUDOARTHOSIS. SCREWS BROKE AT THE BOTTOM LEVEL. NO MORE INFO WAS AVAILABLE AND THE IMPLANTS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIONEER ANTERIOR CERVICAL PLATE SYSTEM BONE SCREW, CERVICAL JDN PIONEER SURGICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention