BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1822665 · Received August 27, 2010

    Report

    Report Number
    1030489-2010-01101
    Event Type
    Injury
    Date Received
    August 27, 2010
    Report Date
    August 2, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NKB
    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 MFR CANNOT DETERMINE THE SUSPECT DEVICE. THE SCREWS THAT WERE USED ARE LOT # W05L1263, W05L1266, AND W05L1268. (B)(4). THE MFR DATE FOR LOT W05L1263 IS 02/22/2007; THE MFR DATE FOR BOTH LOTS W05L 1266 AND W05L 1268 IS 01/02/2006. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. 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 PT UNDERWENT A PLIF USING CAGE AND POSTERIOR FIXATION AT L5-S1. ONE OF THE L5 SCREWS WAS FOUND MIGRATED IMMEDIATELY POST OP. THE REVISION SURGERY WAS PERFORMED THREE DAYS POST OP. THE FIXATION LEVEL WAS EXTENDED TO L4. THE FIXATION SCREW WAS NOT IMPLANTED AT L5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM BONE SCREW NKB WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention CAGE| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| SET SCREWS| EXPLANTED:| PEDICLE SCREWS