BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 2029851 · Received March 25, 2011

    Report

    Report Number
    1030489-2011-00342
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 1, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOTS THAT WERE USED ARE LOT 00998993W, EXPIRATION DATE 06/05/2018; LOT 0099815W EXPIRATION DATE 06/19/2018; LOT 0120955W, EX PIRATION DATE 10/22/2018. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8293640, 510K # K030285 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT 00998993W IS 06/11/2010; THE MANUFACTURE DATE FOR LOT 0099815W IS 06/15/2010; THE MANUFACTURE DATE FOR LOT 0120955W IS 10/29/2010. DEVICE HISTORY RECORDS FOR THOSE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. PER THE REPORTER, THE REPORTED EVENT WAS NOT RELATED TO THE DEVICE. ALTHOUGH WE DO NOT BELIEVE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS REPORT FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLF AT L3/4 USING POSTERIOR FIXATION INSTRUMENTATION. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEM. HOWEVER, THE PATIENT DEVELOPED BLEEDING OF 2000ML AT OPERATIVE SITE AFTER EX-TUBATION POST OP. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL DUE TO TREATMENT DIFFICULTY AT CURRENT ONE. AT THE SECOND HOSPITAL, THE PATIENT WAS RECEIVED THE ASPIRATION PROCEDURE AND WAS ADMINISTERED HAEMOSTATIC FOR THE BLEEDING. NO VESSEL INJURY WAS FOUND. THE AREA OF BLEEDING POINT WAS UNKNOWN. IT WAS CONFIRMED THAT LOSS OF BLOOD VOLUME WAS 5000ML IN THE SECOND HOSPITAL. THE PATIENT RETURNED TO THE FIRST HOSPITAL AT THIS TIME AND IS PRESENTLY STABLE. IT IS NOT BELIEVED THAT THE PROCEDURE AND/OR PRODUCTS CAUSED THE EVENT. THE REASON OF THE BLEEDING IS STILL UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL SYSTEM KWP WARSAW ORTHOPEDIC, INC. NA 0098993W

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention