BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 10647717 · Received October 8, 2020

    Report

    Report Number
    1030489-2020-01399
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Report Date
    October 8, 2020
    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

    PRODUCT IS NOT MARKETED IN US. 510K NO. FOR SIMILAR PRODUCT MARKETED IN US WITH CATALOGUE #9690025 IS K043488. 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 VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF ADULT DEFORMITY. IT WAS REPORTED THAT THE SET SCREW OF S2AI SCREW BACKED OUT, SO ROD HAD REACHED NEAR THE SKIN, AND IT WAS SUSPECTED TO BE INFECTED FROM THERE, ROD WAS CUT BETWEEN L3-4 AND THE SCREW BELOW L4 WAS REMOVED. THE FIXATION ABOVE L3 WAS REMAINED AS IT WAS. THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT HEALTH DAMAGE IN THE PATIENT WAS REPORTED. ROD AND BREAK-OFF SET SCREW IS PARTIAL EXPLANTED. OTHER TWO SCREWS WERE COMPLETELY EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114014 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS 1606300500 0521318W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R