BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLORADO 2 SPINAL SYSTEM

    MDR report key: 1342487 · Received January 22, 2009

    Report

    Report Number
    1030489-2009-00072
    Event Type
    Malfunction
    Date Received
    January 22, 2009
    Date of Event
    December 24, 2008
    Report Date
    December 24, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECS. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG#: 8639300, 510#: K052054 WAS CLEARED IN THE UNITED STATES

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A PLF FOR L4/5 DISCOPATHY AT L2-S1 USING POSTERIOR FIXATION. IT WAS REPORTED THAT ONE LOCKING SCREW COULD NOT BE PLACED TO SECURE THE SACRAL SCREW AT RIGHT SIDE BECAUSE THE SACRAL SCREW WAS NOT SUFFICIENTLY TIGHTENED. THE PROCEDURE WAS COMPLETED WITHOUT THE LOCKING SCREW BEING IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLORADO 2 SPINAL SYSTEM LOCK SCREW KWP WARSAW ORTHOPEDIC INC. NA W08E1186

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR