BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 11249631 · Received January 29, 2021

    Report

    Report Number
    1030489-2021-00109
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Report Date
    January 29, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 55811015540, 510K # K122433 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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A FIELD CONTACT REGARDING A PATIENT UNDERGOING A REMOVAL PROCEDURE DUE TO BONE FUSION. IT WAS REPORTED THAT THE SHAFT OF THE SCREW INSERTED TO THE RIGHT OF L2 WAS BROKEN. THE BROKEN SHAFT WAS COMPLETELY REMOVED USING PSE1. NO FRAGMENTS WERE LEFT IN THE PATIENT. IMPLANT REMOVAL WAS PERFORMED AS THE PATIENT ACHIEVED SOLID BONE FUSION. THERE WERE NO PATIENT SYMPTOMS/COMPLICATIONS AS A RESULT OF THIS EVENT. THE PRODUCT WAS DISCARDED AND WILL NOT BE REPLACED. DATE OF INITIAL SURGERY: (B)(6) 2020 INITIAL SURGERY DETAILS: BURST FRACTURE OF L1; PLF AT T12-L2 MDT PRODUCTS USED IN INITIAL SURGERY: LONGITUDE 5.5/6.0 DEVICE STATUS REASON : EXPLANTED-COMPLETE ADDITIONAL INFORMATION RECEIVED. THE IMPLANT WAS BROKEN DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151213 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC 55711015540 CA18F061

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR