BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTERPIECE¿ PLATE FIXATION SYSTEM

    MDR report key: 5705673 · Received June 8, 2016

    Report

    Report Number
    1030489-2016-01704
    Event Type
    Malfunction
    Date Received
    June 8, 2016
    Report Date
    May 18, 2016
    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 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH CERVICAL SPONDYLOTIC MYELOPATHY UNDERWENT A SPINAL PROCEDURE. POST OP ON AN UNKNOWN DATE THE SCREW OF LAMINA MIGRATED. REVISION WAS NOT SCHEDULED. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361691 CENTERPIECE¿ PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS NA 0427454W

    Patients

    Seq Age Sex Outcome Treatment
    1