BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTERPIECE PLATE FIXATION SYSTEM

    MDR report key: 7094726 · Received December 7, 2017

    Report

    Report Number
    1030489-2017-02466
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 9, 2017
    Report Date
    December 7, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NQW
    PMA / PMN Number
    REFER H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 853-465,510K # K050082 AND UDI (B)(4) IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PATIENT UNDERWENT LAMINOPLASTY DUE TO CERVICAL SPONDYLOTIC MYELOPATHY. ALLEGEDLY POST-OP, THE SCREW IN THE LAMINA SIDE BACKED OUT. THE SCREW STILL REMAINS IN THE PATIENT. AS THERE WERE NO SYMPTOMS IN PARTICULAR, REVISION SURGERY WAS NOT SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877496 CENTERPIECE PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1