BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8507833 · Received April 12, 2019

    Report

    Report Number
    1030489-2019-00411
    Event Type
    Injury
    Date Received
    April 12, 2019
    Report Date
    April 12, 2019
    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
    PHYSICIAN

    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 APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO LOOSENING OF ILIAC SCREWS. WHERE SCREWS HAVE BEEN REPLACED AND SET SCREWS AND ROD HAVE BEEN IMPLANTED AT S2AI. POST-OP, THREE MONTHS AFTER THIS OPERATION, THE IMPLANTED ROD DEVIATED. PATIENT WAS AMBULATORY AFTER THE OPERATION, BUT THE PATIENT BECAME DIFFICULT TO WALK DUE TO THE MALFUNCTION OF THE PRODUCT. ANOTHER, REVISION SURGERY HAS BEEN PERFORMED AS A RESULT OF THIS EVENT AND DOCTOR FOUND THAT THE ROD LENGTH WAS NOT ENOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303687 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0628034W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R