BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2642130 · Received July 6, 2012

    Report

    Report Number
    1030489-2012-01099
    Event Type
    Injury
    Date Received
    July 6, 2012
    Report Date
    June 7, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQP
    PMA / PMN Number
    K050809
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CATALOG # Y7223070, Y7225545, Y7225540, Y7225535 WITH 510K # K050809 WAS CLEARED IN THE UNITED STATES. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: Y7223070 / LOT: W06B1337 (X2), MANUFACTURED: FEB 8, 2006 PART: Y7225545 / LOT: W08E3270, MANUFACTURED: MAY 22, 2008 PART: Y7225540 / LOT: W05J6445, MANUFACTURED: OCT 22, 2005 PART: Y7225535 / LOT: W05J6445 (X2), MANUFACTURED: OCT 22, 2005 PART: Y7225540 / LOT: W05J6446, MANUFACTURED: OCT 22, 2005 ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT IS UNKNOWN. (B)(6). (B)(4) - (MIGRATION OF DEVICE OR DEVICE COMPONENT). 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 STUDY WAS CONDUCTED TO CHARACTERIZE THE REASONS FOR REVISION, HISTOLOGICAL RESPONSES, MECHANISMS OF SURFACE CHANGES, AND CRYSTALLINITY CHANGES OF RETRIEVED PEEK RODS USED IN POSTERIOR SPINAL INSTRUMENTATION. ELEVEN FIXATION SYSTEMS (9 PEEK AND 2 METALLIC SYSTEMS) WERE COLLECTED AFTER REVISION SURGERY, PROVIDING 17 PEEK RODS FOR ANALYSIS. IT WAS REPORTED THAT ONE PATIENT UNDERWENT A REVISION SURGERY AT L/4 5- L5/S1 DUE TO "SCREW LOOSENING" AFTER "(B)(6) YEARS IN-VIVO". REPORTEDLY, THE PATIENT WAS NOT REVISED DUE TO ROD FRACTURE AND THIS PATIENT WAS NOT A RECIPIENT OF TISSUE. NO OTHER PATIENT COMPLICATIONS WERE REPORTED. NO ADDITIONAL RESULTS FROM THE STUDY WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NQP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PEEK RODS AND PEEK MAS SCREWS