BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 11264715 · Received February 2, 2021

    Report

    Report Number
    1030489-2021-00118
    Event Type
    Malfunction
    Date Received
    February 2, 2021
    Report Date
    February 2, 2021
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS NOT MARKETED IN US. 510K FOR SIMILAR PRODUCT MARKETED IN US WITH CATALOGUE#: 778126565 IS K090390. 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 SCREW BACK OUT AND ROD BROKEN. IT WAS A REVISION SURGERY. INITIAL SURGERY IS DONE ON (B)(6) 2019, TLIF WAS PERFORMED ON ONE INTERVERTEBRAL DISC. ON (B)(6) 2017, REOPERATION WAS PERFORMED ON T4-S2AI. ON 2017.5.31, REPLACEMENT OF VERTEBRAL BODY WAS PERFORMED BECAUSE L4 WAS COLLAPSED. ON (B)(6) 2019, S1 AND S2AI SCREWS WERE REPLACED (SET SCREW BACKED OUT). ON 2019.7.10, S1 AND S2AI SCREW REPLACEMENT + EXTENSION TO IL WAS DONE BECAUSE SET SCREW BACKED OUT. IT WAS REPORTED THAT THE SET SCREW ON THE C SIDE OF THE MRC O / C INSERTED BETWEEN THE LEFT L2 AND L3 BACKED OUT. ROD WAS BROKEN BETWEEN LEFT L3-4.LEGACY CLOSED MAS F8.5X80 SCREW OF THE LEFT S2AI WAS BROKEN ON THE BASE. ROD WAS BROKEN BETWEEN THE RIGHT L2-3.SET SCREW OF THE RIGHT S1 BACKED OUT. LEGACY CLOSED MAS F8.5X80 SCREW OF THE RIGHT S2AI WAS BROKEN ON THE BASE. HENCE ON (B)(6) 2021, ALL THE RODS, CONNECTORS, AND LEGACY CLOSED MAS WERE REMOVED AND REPLACED, AND THE OPERATION WAS COMPLETED. THERE WERE FRAGMENTS OF THE IMPLANTS REMAINED IN THE PATIENT BODY. TWO S2AI LEGACY CLOSED MAS8.5X80 SCREWS REMAINING IN THE SACRAL ILIAC PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164708 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS 778326565 0451915W

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention