BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 12156934 · Received July 13, 2021

    Report

    Report Number
    1030489-2021-00914
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Date of Event
    June 16, 2021
    Report Date
    July 13, 2021
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: COUNTRY: (B)(6). THIS DEVICE IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG # 1606200500, 510K# K131321 AND UDI# (B)(4) IS APPROVED FOR SALE IN US. 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 (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF BONE UNION FAILURE BETWEEN L5/S IN NEED OF LEFT APPROACH PLIF BETWEEN L5/S AND L3-S2 ROD CONNECTION IN SPINAL THERAPY. IT WAS REPORTED THAT THE INITIAL SURGERY OF TLIF AT L5/S WAS PERFORMED ON (B)(6) 2018 AND THE SCREWS WERE INSERTED SEGMENTALLY FROM TH10 TO S2AI. THE¿BONE UNION FAILURE OCCURRED BETWEEN L5/S, AND ROD WAS BROKEN LEFT AND RIGHT. A 500MM ROD WAS CUT WITH A CUTTER AND USED FOR THE LEFT AND RIGHT RODS. THE PATIENT HAD PAIN. THE PARTIAL REMOVAL OF THE BROKEN ROD AND ADDITIONAL BONE GRAFTING (PLIF) ON L5 / S WERE PERFORMED ON (B)(6) 2021, AND THE ROD WAS CONNECTED AGAIN.¿LATERAL CONNECTOR WAS PLACED ON THE LEFT S2 AND S1, AND 6.0MM CCM WAS CONNECTED TO THE ROD BETWEEN L3 / 4 BY MRC.¿A 6.0MM CCM WAS PASSED THROUGH THE RIGHT S2 AND S1, L5 WAS CONNECTED TO THIS USING A LATERAL CONNECTOR, AND WAS CONNECTED TO THE ROD BETWEEN L3 AND 4 BY MRC.¿IN ADDITION, 6.0 MM CCM WAS CONNECTED TO THE RIGHT S2 CAUDAL ROD BY MRC AS AN ACCESSORY ROD, AND CROSSLINK WAS USED BETWEEN THE RIGHT L2 / 3 AND CONNECTING WAS PERFORMED.¿THE ACCESSORY ROD AND THE NEW ROD ON THE LEFT WERE CONNECTED USING CROSSLINK.¿THE PATIENT ISSUE HAS RESOLVED AFTER THE REVISION SURGERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056738 CD HORIZON SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB WARSAW ORTHOPEDICS 1606300500 0593442W

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention