BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 12511253 · Received September 22, 2021

    Report

    Report Number
    1030489-2021-01190
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    September 3, 2021
    Report Date
    September 22, 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

    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. 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. THIS EVENT IS SERIOUS INJURY REPORTABLE. SINCE THE DEVICE IS NOT MARKETED IN THE US, THE DEVICE IS REPORTED AS A MALFUNCTION FOR A SIMILAR DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412786 CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB WARSAW ORTHOPEDICS 1556300500 0801118W

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R