BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTOURED CROSSBAR MEDIUM 5.5 ROD

    MDR report key: 4115172 · Received August 28, 2014

    Report

    Report Number
    2032593-2014-00042
    Event Type
    Other
    Date Received
    August 28, 2014
    Date of Event
    July 17, 2014
    Report Date
    August 1, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K061342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE THIRD REPORT OF SIX CONCERNING THE SAME PT. THIS REPORT CONCERNS 12-2052 CONTOURED CROSSBAR MEDIUM 5.5 ROD. IT WAS REPORTED THE PT WAS FIRST OPERATED ON (B)(6) 2014 WHERE SHE UNDERWENT A LUMBAR FUSION PROCEDURE USING 11 MALIBU SCREWS, 2 RODS AND 2 CROSS BARS, 10 X 10CC OF ELIZ AND 10X 5CC OSIQ BONE GRAFT. THE PT LATER PRESENTED AS AN IN-PATIENT AT (B)(6) HOSP IN (B)(6) WITH WOUND INFECTION, A DURAL LEAK AND SEVERE PAIN. SCANS SHOWED SOME MISPLACED SCREWS. THE SURGEON FELT THIS ACCOUNTED FOR THE PAIN AND THE DURAL LEAK. THE SCANS ALSO SHOWED A LARGE VOLUME OF FLUID WITH THE GRAFT MIGRATED OUT TO THE MARGINS OF THE FLUID SACK. THE SURGEON PERFORMED A REVISION SURGERY ON (B)(6) 2014 REMOVING ALL GRAFT AND HARDWARE AND CLEANING OUT THE WOUND. THREE HUNDRED (300) ML OF PUS WAS COLLECTED FROM A SUPERFICIAL SWELLING. THE GRAFT MIGRATED FROM THE SPINE TO THE SOFT TISSUES WITH THE FLOW OF THE FLUID THROUGH A FASCIAL HOLE. THE INFECTION WAS CONFIRMED AS ENTEROCOCCUS FAECALIS. BECAUSE OF THE INFECTION, THE SURGEON DECIDED IT WAS INADVISABLE TO REPLACE THE HARDWARE AND AS THE SPINE APPEARED TO REMAIN STABLE HE SAID THIS SHOULD NOT CAUSE A PROBLEM. THE SOURCE OF THE INFECTION COULD NOT BE CONFORMED. AS AT (B)(6) 2014 THE PT INFECTION WAS RESOLVING, THE WOUND HAS HEALED AND THE PT'S INFLAMMATORY MARKERS ARE DECREASING RAPIDLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526166 CONTOURED CROSSBAR MEDIUM 5.5 ROD MALIBU NKB SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 10 X 10CC OF ELIZ| 10X 5CC OSIQ BONE GRAFT