BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIZE 9 CAGE

    MDR report key: 7373109 · Received March 26, 2018

    Report

    Report Number
    MW5076138
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    March 6, 2018
    Report Date
    March 23, 2018
    Manufacturer
    SPINAL ELEMENTS
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PROCEDURE L4 LAMINECTOMY, L5 LAMINECTOMY, L3 PARTIAL LAMINECTOMY, S1 PARTIAL LAMINECTOMY. TRANSFORAMINAL LUMBAR INTERBODY FUSION L3-4, L4-5, L5-S1, ILIAC CREST ASPIRATION X3, REPAIR OF DURAL TEAR WITH AMNIO PROTECTIVE SHIELD, ALLOGRAFT FOR SPINAL FUSION. DURING INSERTION OF THE CAGE AT L5-S1, PORTION OF CAGE BROKE. SEVERAL ATTEMPTS TO REMOVE REMAINING PIECE MADE UNSUCCESSFULLY. DECISION MADE BY SURGEON TO INSERT FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214790 SIZE 9 CAGE APPLIANCE FIXATION SPINAL INTERVERTEBRAL KWQ SPINAL ELEMENTS 140533

    Patients

    Seq Age Sex Outcome Treatment
    1