BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS TRANSLATIONAL SCREWS AND INSTR

    MDR report key: 23047905 · Received September 14, 2025

    Report

    Report Number
    3003120897-2025-00225
    Event Type
    Malfunction
    Date Received
    September 14, 2025
    Date of Event
    July 28, 2025
    Report Date
    September 13, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    HWJ
    UDI-DI
    00763000884574
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER DETAILS ARE UNKNOWN, H3: PRODUCT ANALYSIS: PART # 7080911; LOT # MA08E036, VISUAL AND FUNCTIONAL INSPECTION CONFIRMED THE RETRACTABLE TIP OF THE AWL HAS BROKEN DUE TO 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. 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 DEVICE WAS STRIPPED AND BROKEN. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE HAS STRIPPED ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2501368 ATLANTIS TRANSLATIONAL SCREWS AND INSTR AWL HWJ MEDTRONIC SOFAMOR DANEK USA, INC. 7080911 MA08E036 00763000884574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown