BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE CONTROL¿ SPINAL SYSTEM

    MDR report key: 20961836 · Received December 18, 2024

    Report

    Report Number
    1030489-2024-01710
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    October 9, 2024
    Report Date
    December 18, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    K120368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART#: 3990004, LOT#: NM19A017 VISUAL INSPECTION CONFIRMED THE KNOB ON THE BACK END OF THE SHAFT OF THE INSERTER HAS BROKEN. OPTICAL INSPECTION OF THE FRACTURE AREA CONFIRMED THE KNOB BROKE AT THE LASER WELD. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE PLACED ON THE INSTRUMENT DURING 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 USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL FUSION THERAPY. IT WAS REPORTED THAT THE DEVICE HAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437776 CAPSTONE CONTROL¿ SPINAL SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC 3990004 NM19A017

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown