BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1894911 · Received November 4, 2010

    Report

    Report Number
    1030489-2010-01433
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (PSEUDOARTHROSIS). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO.

    Additional Manufacturer Narrative · 1

    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

    FOR ALL MAS, THE CROWNS ARE SHOWING IMPACTIONS DUE TO TIGHTENING WITH A SPINAL ROD. FOR 9X MAS THE IMPACTIONS ARE SYMMETRICAL AND ARE CONSISTENT WITH A NEUTRAL LOADING ON THE CONNECTION HEAD. FOR 1X MAS, THE IMPACTIONS ARE ASYMMETRICAL, CONSISTENT WITH THE TRANSMISSION OF FLEXURAL LOADING OF THE CONNECTION HEAD. THE HEADS OF SOME MAS PRESENT SCRATCHES COMING FROM THE EXPLANTATION MANEUVERS. NO SPECIFIC SIGNS OF LOOSENING OR METAL WEAR HAVE BEEN FOUND. NO BONE SCREW HAS BEEN FOUND BROKEN. A PORTION OF BONE THREAD HAS BEEN RETURNED. THE FINISHING AND THE WEIGHT OF THE PART INDICATED IT IS MADE OF STAINLESS STEEL AND IS PROBABLY THE BONE SCREW THREAD COMING FROM A PREVIOUS SURGERY AS DESCRIBED IN THE REPORT EVENT. THIS PART IS NOT RELATED TO THE OTHER CD HORIZON LEGACY 5.5 TITANIUM IMPLANTS RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A FUSION SURGERY TO TREAT DEGENERATIVE DISCOPATHY AT THE LUMBOSACRAL SEGMENT. AN UNK TIME POST-OP, THE PT WAS DIAGNOSED WITH A NON-UNION. THE PT UNDERWENT A REVISION SURGERY TO TREAT THE NON-UNION.

    Description of Event or Problem · 1

    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 55 YR Required Intervention