BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 12710108 · Received October 28, 2021

    Report

    Report Number
    1030489-2021-01320
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Report Date
    October 28, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE WITH CATALOG # 1474000500, 510K # K091974, UDI# (B)(4) IS APPROVED FOR SALE IN THE 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

    THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH EOS FOR SPINAL THERAPY. THE ROD WAS BROKEN DURING THE USE PERIOD OF THE GROWING ROD, SO THE BROKEN ROD WAS REPLACED. THERE WAS A DELAY IN OVERALL PROCEDURE TIME OF MORE THAN 60MINUTES. THERE WAS A REVISION OF SURGERY FOR REPLACEMENT DUE TO A BROKEN ROD. THERE WAS NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607056 CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB WARSAW ORTHOPEDICS 1474100500 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention