BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON X10 CROSSLINK

    MDR report key: 21355653 · Received February 11, 2025

    Report

    Report Number
    1030489-2025-00716
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 30, 2024
    Report Date
    February 11, 2025
    Manufacturer
    MSD BARTLETT MFG
    Product Code
    LXH
    UDI-DI
    00721902744600
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. H3: PRODUCT ANALYSIS OF PART# 8110530, LOT# ID07D010 VISUAL INSPECTION CONFIRMED A PORTION OF THE HEX DRIVER HAS BROKEN. OPTICAL INSPECTION REVEALED A FLAT BRITTLE SURFACE FRACTURE. THIS TYPE OF DAMAGE IS CONSISTENT WITH BEND STRESS OVERLOAD. H11: THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392. 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 USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT USED IN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE IS NO PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1753388 CD HORIZON X10 CROSSLINK ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MSD BARTLETT MFG 8110530 ID07D010 00721902744600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown