BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULEX

    MDR report key: 23093790 · Received September 19, 2025

    Report

    Report Number
    3005677016-2025-00001
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    July 31, 2025
    Report Date
    September 19, 2025
    Manufacturer
    MEDTRONIC (CHANGZHOU) MEDICAL DEVICES TE
    Product Code
    LXH
    UDI-DI
    00763000583750
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3. DEVICE EVALUATION SUMMARY: PRODUCT ANALYSIS #: (B)(4). LOT# K23G1103 VISUAL AND FUNCTIONAL TESTING IDENTIFIED THAT THE ONE OF THE HANDLE LOCKING PINS IS BOKE AT THE LASER WIELD. THE INSTRUMENT CANNOT FUNCTION AS INTENDED. 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 USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSTRUMENT WAS MISSING A PIN WHICH IS NECESSARY FOR PROPER FUNCTION. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270216 MODULEX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC (CHANGZHOU) MEDICAL DEVICES TE 5599130 K23G1103 00763000583750

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown