BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2045938 · Received April 8, 2011

    Report

    Report Number
    1030489-2011-00392
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 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
    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 0119944W, EXPIRATION DATE 10/13/2018; LOT 0120951W, EXPIRATION DATE 10/21/2018; LOT 0126230W, EXPIRATION DATE 11/15/2018. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7540120, 510K # K052187 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT 0119944W IS 10/20/2010; THE MANUFACTURE DATE FOR LOT 0120951W IS 10/29/2010; THE MANUFACTURE DATE FOR LOT 0126230W IS 11/22/2010. 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 UNDERWENT A SPINAL SURGERY TO IMPLANT POSTERIOR FIXATION AND INTERBODY DEVICE AT L4-L5. IT WAS FOUND THAT THE SET SCREW WAS LOOSENED AT UNKNOWN TIME POST OP. THE REVISION SURGERY WAS PERFORMED 5 WEEKS POST OP. REPORTEDLY, THE PEDICLE SCREW WAS REPLACED DURING THE REVISION SURGERY. NO PATIENT COMPLICATIONS WERE REPORTED DURING AND AFTER THE REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention INTERBODY DEVICE, PEDICLE SCREWS, CROSSLINK