BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-1

    MDR report key: 3783387 · Received April 25, 2014

    Report

    Report Number
    3783387
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 13, 2014
    Manufacturer
    INION, INC
    Product Code
    OJB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT IN SURGERY FOR ANTERIOR CERVICAL DISCECTOMY WITH FUSION. DURING SURGERY, 3 INION CERVICAL PLATES CRACKED WHILE SURGEON WAS POSTING THEM TO THE PATIENT'S CERVICAL VERTEBRAE. IT APPEARS THE CORRECT TEMPERATURE OF THE WATER MAY NOT HAVE BEEN MET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251877 S-1 RESORBABLE SPINAL INTERVERTEBRAL OJB INION, INC * 1301002 1303026X2

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR UNKNOWN,