BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 3042812 · Received April 9, 2013

    Report

    Report Number
    1030489-2013-00953
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    NKB
    PMA / PMN Number
    K113174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION:ANALYSIS OF THE RETURNED DEVICE SHOWS THAT MACROSCOPIC AND OPTICAL EXAMINATION REVEALED THREAD CREST AND FLANK DAMAGE; THIS DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD, AND IS CONSISTENT AROUND THE DAMAGED PORTION OF THE THREADS. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISALIGNMENT OF THE CONNECTOR AND SET SCREW THREADS DURING CONSTRUCT ASSEMBLY.

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE, DURING THE PROCEDURE IT WAS REPORTED THAT THE THREADS OF THE SET SCREW WERE SHEARING AND PREVENTED ADVANCEMENT OF THE SET SCREW INTO THE SCREW HEAD. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145290 CD HORIZON® SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS 5540030 H12K0610

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR