BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2642132 · Received July 6, 2012

    Report

    Report Number
    1030489-2012-01101
    Event Type
    Injury
    Date Received
    July 6, 2012
    Report Date
    June 7, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NQP
    PMA / PMN Number
    K113174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CATALOG # 7893070 AND 7893080 WITH 510K # K052609; CATALOG # 7896545, 7896535 WITH 510K # K050809 WAS CLEARED IN THE UNITED STATES. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 7893070 / LOT: W07H0367, MANUFACTURED: AUG 02, 2007 PART: 7893080 / LOT: W07H0948, MANUFACTURED: AUG 06, 2007 PART: 7896535 / LOT: W07E3860, MANUFACTURED: MAY 23, 2007 PART: 7896535 / LOT: W07E3772, MANUFACTURED: MAY 22, 2007 PART: 7896545 / LOT: W07E4569 (X3), MANUFACTURED: MAY 29, 2007 PART: 7896545 / LOT: 0003133W, MANUFACTURED: DEC 02, 2008 PART: 7896545 / LOT: W07L4356, MANUFACTURED: NOV 20, 2007 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

    LITERATURE ARTICLE CITATION: HIGGS, G.B. ET AL., "RETRIEVAL ANALYSIS OF PEEK RODS FOR POSTERIOR LUMBAR STABILIZATION AND FUSION". WWW.MEDICALPEEK.ORG. DATE OF EVENT IS UNKNOWN. (B)(6). (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. ALTHOUGH IT IS UNKNOWN IF A MEDTRONIC DEVICE CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    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 WAS REVISED AT L4/L5 - L5/S1 AFTER ONE YEAR DUE TO PAIN. REPORTEDLY, THE PATIENT WAS NOT REVISED DUE TO ROD FRACTURE AND THIS PATIENT WAS A RECIPIENT OF TISSUE. IMAGES WERE TAKEN OF THE PATIENT'S PERIPROSTHETIC TISSUE MORPHOLOGY AND SHOWED EVIDENCE OF INFLAMMATION AND TISSUE DEGENERATION. 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 00065 YR Required Intervention PEEK RODS AND NON-CANNULATED MAS SCREWS