BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTERPIECE PLATE FIXATION SYSTEM

    MDR report key: 3824231 · Received May 21, 2014

    Report

    Report Number
    1030489-2014-02595
    Event Type
    Injury
    Date Received
    May 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NQW
    PMA / PMN Number
    SEE H10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGING INTERPRETATION: THIS PATIENT UNDERWENT LAMINOPLASTY AT C4-C7. POSTOP PARALYSIS DEVELOPED IN THE RIGHT ARM AND HAND. ALL HINGES ON IMPLANT WERE NOTED TO BE BROKEN FORCING REVISION AND REMOVAL. CERVICAL CT SHOWS THE LAMINOPLASTY WITH WHAT APPEARS A FRACTURE THROUGH THE REMAINING BONY BRIDGES. THE IMPLANTED DEVICE REMAINS INTACT HOWEVER THE INTACT BONE BRIDGE ON THE RIGHT HAS DISPLACED ALLOWING A BONY SPICULE TO TRANSLATE ANTERIORLY IMPINGING THE CORD.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG #S 8530008 AND 510K # K050082 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL LAMINOPLASTY WITH USING A PLATE FIXATION SYSTEM AT C4-C7. SOMETIME POST-OPERATIVELY, THE PATIENT DEVELOPED PARALYSIS (ONSET DATE UNKNOWN). ALL HINGES ON THE PLATE SYSTEM WERE REPORTEDLY BROKEN AND THE PATIENT WAS UNABLE TO MOVE THEIR RIGHT HAND. SEVEN DAYS POST-OP, A REVISION SURGERY WAS PERFORMED TO REMOVE THE IMPLANTS AT C4-C7. THE SURGEON COMMENTED THAT THE BREAKAGE MAY HAVE OCCURRED DUE TO OVERLOADING DURING SCREW INSERTION AND STATED THAT "IT WAS HARD TO LESSEN THE LOAD EVEN BY PUSHING LAMINA WITH KOCHER CLAMPS OR HOLDING PLATE BY A HOLDER". REPORTEDLY, THE PLATE HINGES SEEMED TO BE PLACED "INNER" BASED ON CT SCAN IMAGES. ACCORDING TO THE REPORT, THE SURGEON HAS PERFORMED OPEN-DOOR LAMINOPLASTIES "BY SUSPENDING HINGES BY STRINGS" AND "WOULD SCRAPE HINGES THINNER TO PREVENT DISCLOSURE AND HOLD THEM A BIT HIGHER IN THIS SURGERY". THIS TECHNIQUES REPORTEDLY MAY HAVE CONTRIBUTED TO THE INCIDENT. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301825 CENTERPIECE PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS NA 0271010W

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention 2.6 X 5MM SCREWS