BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8740186 · Received June 27, 2019

    Report

    Report Number
    1030489-2019-00670
    Event Type
    Injury
    Date Received
    June 27, 2019
    Report Date
    June 27, 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

    PMA/510K #: THIS PART IS NOT APPROVED FOR SALE IN UNITED STATES; HOWEVER, A LIKE DEVICE WITH CATALOG# 1556006300, 510(K)# K121680 AND UDI # (B)(4), IS APPROVED FOR SALE IN UNITED STATES. 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 WAS PRE-OPERATIVELY DIAGNOSED WITH KYPHOSCOLIOSIS WITH CHIEF COMPLAINT OF BACK PAIN. ON (B)(6) 2017, SHE UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF)/ POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AND POSTERIOR FIXATION. ON AN UNKNOWN DATE BETWEEN (B)(6) 2018 TO (B)(6) 2018, POST-OP, THE ROD, WHICH CONNECTED T10-S2, BROKE AT L5-S1 ON BOTH SIDES. THE PATIENT ALSO REPORTED BACK PAIN. IT WAS ALLEGED THAT THE BREAKAGE WAS DUE TO BONE UNION FAILURE BETWEEN L5-S1. ON (B)(6) 2019, THE REVISION SURGERY WAS PERFORMED WHEREIN THE BROKEN PART WAS REMOVED. NO OTHER NOTABLE COMPLICATIONS WERE REPORTED. THERE WAS BLOOD ON THE REMOVED ROD, SO THE ROD WAS DISCARDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534059 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0562557W

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention