BEUDAMED
    FDA Adverse Event Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 2224695 · Received August 26, 2011

    Report

    Report Number
    1030489-2011-01108
    Date Received
    August 26, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 27, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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 PART# (B)(4) LOT 0121907W, EXPIRATION DATE 10/18/2018; LOT 0129767W, EXPIRATION DATE 02/08/2019; LOT 0142893W, EXPIRATION DATE 2/22/2019; LOT 0142894W, EXPIRATION DATE 03/1/2019; LOT 0149601W, EXPIRATION DATE 02/21/2016. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8281248, 510K # K041282 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT 0121907W IS 10/25/2010; THE MANUFACTURE DATE FOR LOT 0129767W IS 12/20/2010; THE MANUFACTURE DATE FOR LOT 0138581W IS 2/14/2011; THE MANUFACTURE DATE FOR LOT 0142893W IS 2/28/2011; THE MANUFACTURE DATE FOR LOT 0142894W IS 3/08/2011' THE MANUFACTURE DATE FOR LOT 0149601W IS 2/28/2011. 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 UNDERWENT A TWO LEVEL POSTERIOR INTERBODY FUSION. IT WAS REPORTED THAT SIX DAYS POST OP THE SURGEON FOUND A FRAGMENT OF THE LOCKING SCREW WAS LEFT IN THE PATIENT. NO REVISION SURGERY WILL BE PERFORMED, NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other RODS, SCREWS