BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON, INC

    MDR report key: 469799 · Received June 27, 2003

    Report

    Report Number
    469799
    Event Type
    Injury
    Date Received
    June 27, 2003
    Date of Event
    June 4, 2003
    Report Date
    June 26, 2003
    Manufacturer
    ETHICON, INC
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO HOSPITAL FOR DECOMPRESSIVE CERVICAL LAMINECTOMY C-7 AND T1, POSTEROLATERAL FUSION WITH INSTRUMENTATION, C6, C7, T1 AND T2 WITH INTERSPONOUS CABLING FROM C6 TO T2 AND LATERAL MASS SCREWS AT C6, PEDICLE SCREWS AT C7, T1 AND T2 WITH THE STARLOCK SYNTHES TITANIUM SYSTEM. THE NECK WAS DRAINED WITH A 10 FR FULLY FLUTED BLAKE DRAIN EXITING TO THE RIGHT. TWO DAYS LATER THE SURGEON WAS IN THE PROCESS OF REMOVING THE DRAIN WHEN IT SNAPPED OFF AT THE SKIN LEVEL. PT WAS RETURNED TO SURGERY FOR REMOVAL OF DRAIN. THE RETAINED DRAIN WAS FOUND FLOATING IN THE MIDLINE OF THE INCISION WITH NO APPARENT SUTURE THROUGH IT OR ANYTHING ELSE THAT KEPT IT FROM BEING REMOVED ORIGINALLY. PATHOLOGY REPORT OF REMOVED DRAIN NOTED IT WAS 8.5 CM IN LENGTH AND UP TO 0.25 CM IN DIAMETER. THE PROXIMAL PORTION SHOWED AN IRREGULAR RAGGED PROXIMAL MARGIN WHICH MEASURED 1.5CM. THE REMAINDER OF THE DRAIN WAS SOFT WHITE PLASTIC WITH FOUR LONG LONGITUDINAL GROOVES ALONG THE OUTER SURFACE. PT DISCHARGED IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON, INC BLAKE DRAIN GCY ETHICON, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other| R