BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPINELINK ANTERIOR CERVICAL SYSTEM

    MDR report key: 283411 · Received June 22, 2000

    Report

    Report Number
    2242816-2000-00012
    Event Type
    Other
    Date Received
    June 22, 2000
    Date of Event
    May 18, 2000
    Report Date
    June 22, 2000
    Manufacturer
    EBI, L.P.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT OF A PT WITH ESOPHAGEAL FISTULA, OSTEOMYELITIS AND PARAPLEGIA WAS REC'D. THE PT HAD UNDERGONE CERVICAL SPINAL FIXATION WITH THE SPINELINK ANTERIOR CERVICAL SYSTEM APPROXIMATELY ONE YEAR AGO AND WAS SUBSEQUENTLY TREATED WITH A SECOND POSTERIOR CERVICAL SURGERY (HARDWARE UNKNOWN) APPROXIMATELY NINE MONTHS AGO. AT PRESENTATION, THE SPINELINK SYSTEM WAS SUCCESSFULLY REMOVED. INITIAL REPORTS INDICATE THE SYSTEM DID NOT APPEAR TO BE DAMAGED. TO DATE CO HAS BEEN UNABLE TO RETRIEVE THE SPINELINK SCREWS AND LINKS FOR EXAMINATION. ALTHOUGH PRESENTLY THERE IS NO DEFINITIVE CONNECTION BETWEEN SPINELINK AND THE PT'S SYMPTOMS, AN MDR IS BEING FILED FOR INFORMATIONAL PURPOSES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other