BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9688927 · Received February 10, 2020

    Report

    Report Number
    1030489-2020-00160
    Event Type
    Injury
    Date Received
    February 10, 2020
    Report Date
    February 10, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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 USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5440130, 510K # K102555 AND UPI: (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 TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1 AND FIXATION AT L4-ILIAC. THE SIZES OF SET SCREWS THAT WERE USED AT ILIAC DURING THE INITIAL SURGERY WERE: DIAMETER 6.5MM X 55MM LONG AT THE RIGHT; AND DIAMETER 7.5MM X 55MM LONG AT THE LEFT. COBALT-CHROMIUM ROD OF DIAMETER 5.5 MM WAS USED. ON AN UNKNOWN DATE, POST-OP, THE PATIENT PRESENTED WITH BACK PAIN AND THERE WAS NON-FUSION FOR TLIF AT L5-S1. HENCE, A REVISION SURGERY WAS PERFORMED. IN THIS SURGERY, SET SCREW AT THE RIGHT SIDE OF ILIAC BACKED OUT WHEN THE PRODUCT WAS USED TO PERFORM THE PROCEDURE. THE OPERATION, WHICH WAS FUSION FOR EXTENDING AT L1-ILIAC, WAS ALSO PERFORMED AS IT HAD BEEN PLANNED. FIBULA GRAFT WAS PERFORMED AT L5-S1. PATIENT'S COMPLICATIONS AFTER THE REVISION SURGERY ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150989 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H5493160

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention