BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 12553662 · Received September 30, 2021

    Report

    Report Number
    1030489-2021-01225
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Report Date
    September 30, 2021
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    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. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT SPINAL THERAPY FOR DEGEN ERATIVE SCOLIOSIS. IT WAS REPORTED THAT ROD WAS BROKEN BETWEEN L3/L4. THE PROCEDURE INVOLVED IN THE EVENT WAS POSTERIOR DECOMPRESSION AND FUSION OF T10 TO ILIAC AND LEVELS IMPLANTED WAS T10-ILIAC. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE ARE NO PLANS FOR REOPERATION FOR REMOVAL OF BROKEN ROD. THE LOT NUMBER OF THE REPORTED ROD IS 0664446W. THE IMPLANT DATE OF THE ROD IS (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1452705 CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB WARSAW ORTHOPEDICS 1556300500 0664446W

    Patients

    Seq Age Sex Outcome Treatment
    1