BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTERPIECE PLATE FIXATION SYSTEM

    MDR report key: 8834611 · Received July 28, 2019

    Report

    Report Number
    1030489-2019-00835
    Event Type
    Malfunction
    Date Received
    July 28, 2019
    Report Date
    July 28, 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) AND 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. ON AN UNKNOWN DATE, POST-OP, SCREW ON C6 LAMINA SIDE CAME OFF. CURRENTLY, NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AND THERE IS NO PLAN FOR REVISION SURGERY YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628601 CENTERPIECE PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1