BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTERPIECE PLATE FIXATION SYSTEM

    MDR report key: 4136075 · Received October 2, 2014

    Report

    Report Number
    1030489-2014-03781
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH IT IS UNKNOWN IF ANY MEDTRONIC DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CERVICAL LAMINOPLASTY ON AN UNKNOWN DATE (OPERATIVE LEVELS UNKNOWN). POST-OPERATIVE PARALYSIS PERSISTED AND A REVISION SURGERY TO REMOVE THE PLATE WAS PERFORMED ALONG WITH NERVE ROOT DECOMPRESSION. AN ADDITIONAL REVISION SURGERY WAS SCHEDULED TO IMPLANT ANOTHER PLATE. ACCORDING TO THE REPORT, "THE SURGEON CONSIDERED THAT PARALYSIS WAS UNRELATED" TO THE PLATE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616394 CENTERPIECE PLATE FIXATION SYSTEM ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL NQW MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention