BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2735789 · Received September 7, 2012

    Report

    Report Number
    1030489-2012-01569
    Event Type
    Injury
    Date Received
    September 7, 2012
    Report Date
    August 9, 2012
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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) - (NO KNOWN DEVICE PROBLEM). CATALOG # 7893060 WITH 510K # K052609; CATALOG # 7897540, 7897545, 7896550 WITH 510K # K050809 WAS CLEARED IN THE UNITED STATES. 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. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 7893060 / LOT: 0028580W, MANUFACTURED: APR 30, 2009 PART: 7893060 / LOT:0023481W, MANUFACTURED: MAR 19, 2009 PART: 7897540 / LOT: 0003088W, MANUFACTURED: NOV 25, 2008 PART: 7897545 / LOT: W08F1448, MANUFACTURED: JUN 09, 2008, PART: 7896550 / LOT: 0018882W (X2), MANUFACTURED: FEB 02, 2009, PART: 7896550 / LOT: 0005777W, MANUFACTURED: DEC 04, 2008, PART: 7896550 / LOT: 0047164W, MANUFACTURED: JUL 27, 2009, ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES 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 EXPERIENCED PAIN SOMETIME POST-OPERATIVELY AND REQUIRED A REVISION SURGERY AT LEVELS L4-S1. NO ADDITIONAL RESULTS FROM THE STUDY WERE GIVEN AND NO COMPLICATIONS WERE REPORTED.

    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 WARSAW ORTHOPEDIC, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention PEEK RODS AND NON-CANNULATED MAS SCREWS