BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTERPIECE PLATE FIXATION SYSTEM

    MDR report key: 8352838 · Received February 20, 2019

    Report

    Report Number
    1030489-2019-00171
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Report Date
    February 20, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NQW
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT MARKETED IN US BUT A SIMILAR DEVICE WITH CATALOG # 853-465, UDI# (B)(4) 510K# K050082 IS APPROVED FOR SALE IN US. NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE CANNOT DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT CERVICAL LAMINOPLASTY AT C3-C6 DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. TWO WEEKS AFTER THE OPERATION, IT WAS DISCOVERED THAT THE SCREW BACKED OUT AT C3 LAMINA. IT IS UNKNOWN THAT THE SCREW CAME OUT TO WHAT EXTENT; BUT THE IMPLANTED PLATE DID NOT MOVE. THE PRODUCT IS STILL IMPLANTED IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED YET; AND THE PATIENT WOULD BE OBSERVED DURING FOLLOW-UP VISITS. DOCTOR'S COMMENTS: DURING THE INITIAL OPERATION, AS THE GRIP STRENGTH OF DRIVER WAS TOO STRONG AND THE DRIVER WAS HARD TO BE REMOVED, IT WAS REMOVED BY SHAKING. THIS EXPANDED THE PILOT HOLE. ADDITIONALLY, IT WAS DIFFICULT TO VERIFY THE DEPTH AS THE HEAD GOT BIGGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147642 CENTERPIECE PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS NA 0670528W

    Patients

    Seq Age Sex Outcome Treatment
    1