BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2022370 · Received March 17, 2011

    Report

    Report Number
    1030489-2011-00293
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 16, 2011
    Report Date
    March 11, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    PMA / PMN Number
    K052187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SET SCREW WAS RETURNED FOR EVALUATION. THE THREAD CRESTS AND FLANKS ARE SEVERELY DAMAGED; THIS DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD, AND IS CONSISTENT AROUND THE THREAD. OPTICALLY CONFIRMED THAT A PORTION OF THE THREAD IS MISSING, CONSISTENT WITH THE "WIRE" FOUND AFTER CROSS-THREADING OCCURRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR LATERAL FUSION AT L5-S1. IT WAS REPORTED THAT THE SET SCREW WOULD NOT SEAT PROPERLY IN THE RIGHT SCREW AT S1. WHEN THE SCREW WAS REMOVED, THE THREAD OF THE SETSCREW WAS FOUND. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H10D7111

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE SCREW