BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTERPIECE PLATE FIXATION SYSTEM

    MDR report key: 10144618 · Received June 11, 2020

    Report

    Report Number
    1030489-2020-00601
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    May 14, 2020
    Report Date
    June 11, 2020
    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 PRESENTED WITH CERVICAL SPONDYLOTIC MYELOPATHY; AND UNDERWENT UNILATERAL OPEN DOOR LAMINECTOMY. ON AN UNKNOWN DATE, POST-OP, IT WAS CHECKED BY MRI THAT THE SCREW ON THE LAMINA SIDE HAD BACKED OUT. IN THE SURGEON¿S OPINION, THERE MIGHT BE NO PROBLEM BECAUSE THE PLATE IS FIRMLY FIXED. THERE IS NO PLAN TO PERFORM A REVISION SURGERY AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606629 CENTERPIECE PLATE FIXATION SYSTEM NQW WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1