BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 12178998 · Received July 16, 2021

    Report

    Report Number
    1030489-2021-00934
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 28, 2021
    Report Date
    July 16, 2021
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 1556200500, 510K# K131321 AND UDI (B)(4) IS APPROVED FOR SALE IN US. THUS, IT IS REPORTABLE FOR MALFUNCTION, NOT SERIOUS INJURY, ALTHOUGH SURGICAL INTERVENTION DID TAKE PLACE. 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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE THE ROD WAS BROKEN. THERE WAS NO FRAGMENT LEFT IN THE PATIENT. THERE WERE NO SYMPTOMS REPORTED. PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE, REVISION SURGERY WAS PERFORMED DUE TO ROD BREAKAGE DUE TO BONE UNION FAILURE, ROD REPLACEMENT AND BONE GRAFTING. PROCEDURE PERFORMED <(>&<)> LEVEL IMPLANTED WERE OLIF AT 3 INTERVERTEBRAL DISCS AND PSF AT T9/S2AI. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078745 CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB WARSAW ORTHOPEDICS 1556300500 0365013W

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention