BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1822637 · Received August 27, 2010

    Report

    Report Number
    1030489-2010-01106
    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): NON-FUSION- (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 #W05L 1263, W05L 1266, AND W05L 1268. (B)(4): THE MFR DATE FOR LOT W05L 1263 IS 02/22/2007; THE MFR DATE FOR BOTH LOTS W05L 1266 AND W05L 1268 ARE 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 SPINAL PROCEDURE TO IMPLANT POSTERIOR FIXATION AT L4-S1. THE FIXATION SCREWS WERE NOT IMPLANTED TO L5. THE PT REPORTEDLY DID NOT FUSE THREE YEARS AFTER. THE LEFT S1 SCREW WAS BROKEN. THE ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE CONSTRUCT. THE FIXATION LEVEL WAS EXTENDED FROM L4 TO S2 BY A PLF. S1 SCREWS WERE BOTH REPLACED TO THE LARGER SIZED SCREWS. THERE WAS STILL NO SCREW IMPLANT AT L5. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    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 PEDICLE SCREWS| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| ROD| IMPLANTED:| SET SCREWS| IMPLANTED: