BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8830614 · Received July 26, 2019

    Report

    Report Number
    1030489-2019-00823
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Report Date
    July 26, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    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 PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 869-021, 510K #K040962 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT POSTERIOR LUMBAR FIXATION AT L4-ILIAC DUE TO LUMBAR CANAL STENOSIS. ON AN UNKNOWN DATE, POST-OP, ROD BREAKAGE OCCURRED AT L5/S1 (ON BOTH SIDES). IT WAS PLANNED TO REPLACE THE RODS ON (B)(6) 2019, BUT IT UNKNOWN IF THE REVISION HAS BEEN PERFORMED YET. PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT WERE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626438 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0681941W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention