BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTERPIECE PLATE FIXATION SYSTEM

    MDR report key: 8631162 · Received May 22, 2019

    Report

    Report Number
    1030489-2019-00571
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    April 17, 2019
    Report Date
    May 22, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NQW
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG# 853-507, 510K# K050082, (B)(4) WAS CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED 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 LAMINOPLASTY DUE TO CERVICAL SPONDYLOTIC MYELOPATHY (CSM). POST-OP, THE LATERAL MASS SCREW OF THE CENTERPIECE MIGRATED AND ENTERED INTO THE SPINAL CANAL. PATIENT SUFFERED WITH PALSY OCCURRED AT C5 AS A RESULT OF THIS EVENT. THERE IS NOT PLAN FOR REVISION SURGERY YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426411 CENTERPIECE PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW WARSAW ORTHOPEDICS NA 0675599W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other