BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLORADO II SPINAL SYSTEM

    MDR report key: 2178309 · Received July 26, 2011

    Report

    Report Number
    1030489-2011-00943
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K991031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE LOT 0000194W, EXPIRATION DATE 11/13/2016; LOT 0053051, EXPIRATION DATE 09/22/2017; LOT 0114661W, EXPIRATION DATE 09/02/2018. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8632345, 510K # K991031 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT 0000194W IS 11/21/2008; THE MANUFACTURE DATE FOR LOT 0053051W IS 09/28/2009; THE MANUFACTURE DATE FOR LOT 0114661W IS 10/16/2010. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECENTLY UNDERWENT A PROCEDURE VIA TLIF AND PLIF AT T12/S1. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 21 DAYS AFTER THE OPERATION. IT IS SUSPECTED THE TIPS OF THE 2ND (SUB) SACRAL SCREWS VIOLATED L5 ROOTS BECAUSE THE SCREWS WERE TOO LONG FOR THE PATIENT. THE SURGEON REPLACED THE SACRAL SCREWS TO SHORTER ONES, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO IMPACT ON PATIENT OUTCOME AND NO PATIENT COMPLICATION ARE REPORTED AT THIS TIME. DURING THE REVISION SURGERY, THE DURA MATER REPORTEDLY WAS DAMAGED WHEN AN INSTRUMENT WAS BEING INSERTED AT S2 LAMINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLORADO II SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention SET SCREWS, RODS