BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON X10 CROSSLINK

    MDR report key: 11330943 · Received February 16, 2021

    Report

    Report Number
    1030489-2021-00202
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    August 10, 2020
    Report Date
    February 16, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    UDI-DI
    00721902766404
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: PART # 8110540, LOT #: ID10H005 VISUAL AND OPTICAL INSPECTION REVEALED THE TIP OF THE COUNTERTORQUE HAS BEEN DAMAGED. THE EDGES HAVE BEEN WORN DOWN AND DEFORMED THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATED USE OVERTIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LUMBAR FIXATION AND FUSION DUE TO LUMBAR DEGENERATION. IT WAS REPORTED THAT THE CROSSLINK SCREW CAP WAS FOUND BROKEN DURING X-RAY BEFORE THE PATIENT WAS DISCHARGED FROM THE HOSPITAL, AND A PART OF THE SCREW CAP FELL ON THE EPIDURAL OF THE LUMBAR SPINE. THE NUT OF THE X10 CROSSLINK WAS ABNORMALLY BROKEN AND BROKE IN THE PATIENT'S BODY AFTER THE SURGERY. CROSSLINK REMAINS IMPLANTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229670 CD HORIZON X10 CROSSLINK ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC 8110540 ID10H005 00721902766404

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR