BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 2136003 · Received June 21, 2011

    Report

    Report Number
    1030489-2011-00768
    Event Type
    Injury
    Date Received
    June 21, 2011
    Report Date
    May 24, 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# G8293430, LOT W06A0720, EXPIRATION DATE 01/13/2014; LOT W06J2168, EXPIRATION DATE 10/11/2014; PART G8293535, LOT 0044969W, EXPIRATION DATE 08/05/2017; PART G8293530, LOT 0089236W, EXPIRATION DATE 04/08/2018. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8293430, 510K # K031967; PART 8293535 AND 8293530, 510K # K030285 WERE CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT W06A0720 IS 02/16/2006; THE MANUFACTURE DATE FOR LOT W06J2168 IS 11/06/2006; THE MANUFACTURE DATE FOR LOT 0044969W IS 08/12/2009; THE MANUFACTURE DATE FOR LOT 0089236W IS 04/16/20110. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGERY. TWO OF PEDICLE SCREWS WERE BROKEN POST OP. ACCORDING TO THE SURGEON, THE PATIENT HAD FALLEN POST OP, BUT IT SEEMED THAT THE FALL DID NOT AFFECT HIS/HER MOTOR FUNCTIONS. THE PATIENT REPORTED HAD SOME NEUROLOGICAL SYMPTOMS. A REVISION SURGERY WAS PERFORMED 9 MONTHS POST OP TO REMOVE THE BROKEN SCREWS. AT THE REVISION SURGERY ALL IMPLANTS WERE REMOVED. NO OTHER COMPLICATION WAS 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 Required Intervention RODS, SET SCREWS