BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON X10 CROSSLINK

    MDR report key: 20619941 · Received November 6, 2024

    Report

    Report Number
    1030489-2024-01441
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 8, 2024
    Report Date
    November 6, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    UDI-DI
    00721902744600
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: PART # 8110530, LOT # ID07J002 VISUAL INSPECTION CONFIRMED THE TIP OF THE DRIVER IS WORN FROM REPEATED USE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (QUALITY INSPECTOR) REGARDING A PART USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP WAS BROKEN AND INSTRUMENT WAS WORN. THERE WAS NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417478 CD HORIZON X10 CROSSLINK ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC 8110530 ID07J002 00721902744600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown