BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINELINK ANTERIOR CERVICAL SYSTEM

    MDR report key: 483762 · Received September 11, 2003

    Report

    Report Number
    2242816-2003-00009
    Event Type
    Other
    Date Received
    September 11, 2003
    Date of Event
    July 20, 2003
    Report Date
    September 10, 2003
    Manufacturer
    EBI, L.P.
    Product Code
    JDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SPINELINK ANTERIOR CERVICAL SYSTEM HAD PREVIOUSLY BEEN IMPLANTED IN THE PT. AT A RECENT FOLLOW-UP VISIT IT WAS DETERMINED THE PT HAD DEVELOPED AN ERODED ESOPHAGUS. THE HARDWARD WAS SUBSEQUENTLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINELINK ANTERIOR CERVICAL SYSTEM SPINAL FIXATION JDN EBI, L.P. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other