BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2139921 · Received June 25, 2011

    Report

    Report Number
    1030489-2011-00811
    Event Type
    Injury
    Date Received
    June 25, 2011
    Date of Event
    May 27, 2011
    Report Date
    October 11, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION: MACROSCOPIC AND OPTICAL EXAMINATION OF MAS AND SET SCREWS REVEALED THREAD CREST AND FLANK DAMAGE; THIS DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD, AND IS NOTED ON BOTH RETURNED SET SCREWS AND MAS, CONSISTENT WITH MISALIGNMENT OF THE MAS HEAD AND SET SCREW THREADS DURING CONSTRUCT ASSEMBLY.

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE 0150696W, 0150767W, 0150768W, 0150602W, EXPIRATION DATE FOR THESE LOT IS 03/31/2019; LOT 088315W, EXPIRATION DATE 04/07/2018. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8670855, 510K #K000453 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT 0150696W, 0150767W, 0150768W, 0150602W IS 04/06/2011; THE MANUFACTURE DATE FOR LOT 088315W IS 04/16/2010. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). ENLARGED INCISION AND SURGICAL TIME EXTENDED. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL MINI-INVASIVE PROCEDURE AT L3/5. DURING THE FINAL TIGHTENING AT ONE SIDE, THE NUT COULD NOT BE BROKEN OFF AT L5. THE PROCEDURE WAS CHANGED TO AN OPEN PROCEDURE. THE FINAL SURGICAL TIME WAS EXTENDED 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention