BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3173718 · Received June 17, 2013

    Report

    Report Number
    1030489-2013-02338
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    June 11, 2013
    Report Date
    November 4, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MNH
    PMA / PMN Number
    K993810
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT NO COMPLAINT IDENTIFIED WITH REGARD TO THE ASSOCIATED RETURNED IMPLANTS. AFTER VISUAL REVIEW, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANTS. RODS CUT DUE TO CONNECTOR SET SCREW STRIPPING. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH IMPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE WITH HARDWARE IMPLANTATION. AT AN UNKNOWN TIME POST-OP, IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY TO REMOVE THE SET SCREW. DURING THE REVISION, IT WAS REPORTED THAT SURGEON WAS UNABLE TO REMOVE THE SET SCREW AND THUS HAD TO CUT THE ROD ABOVE AND BELOW THE SET SCREW. NEW HARDWARE WAS IMPLANTED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273123 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPONDYLOISTHESIS SPINAL FIXATION MNH MEDTRONIC SOFAMOR DANEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR