BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY

    MDR report key: 19399369 · Received May 27, 2024

    Report

    Report Number
    1030489-2024-00562
    Event Type
    Malfunction
    Date Received
    May 27, 2024
    Date of Event
    May 6, 2024
    Report Date
    May 27, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS PRODUCT ID # 3606195 LOT NO. # K23E1056 VISUAL AND OPTICAL INSPECTION CONFIRMED THE THREADED PIN IS MISSING FROM THE SCREWDRIVER SHAFT. OPTICAL INSPECTION CONFIRMED DAMAGE AROUND THE THROUGH WHOLE. THE PIN APPEARS TO HAVE BROKE DUE TO BEND STRESS OVERLOAD. 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 HEALTHCARE FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSTRUMENT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE CROSS-BAR IN THE TIP OF THE DRIVER WAS MISSING. THE DRIVER WAS IN TWO SEPARATE PIECES - THE SLEEVE AND SHAFT. THERE WAS NO PATIENT INVOLVED AT THE TIME OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307465 INFINITY APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC 3606195 K23E1056

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown