BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS TRANSLATIONAL SCREWS AND INSTRUMENT

    MDR report key: 21236320 · Received January 25, 2025

    Report

    Report Number
    1030489-2025-00347
    Event Type
    Malfunction
    Date Received
    January 25, 2025
    Date of Event
    October 11, 2023
    Report Date
    January 25, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HWJ
    UDI-DI
    00613994236098
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS # (B)(4): PART # 7080911, LOT # EM10K026 VISUAL INSPECTION CONFIRMED THE AWL TIP HAS BEEN BENT. THIS TYPE OF DAMAGE IS CONSISTENT WITH BEND STRESS OVERLOAD. 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 HEALTHCARE FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING AN AWL USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE AWL WAS BROKEN. PRODUCT WILL BE RETURNED. THERE WAS NO PATIENT INVOLVED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549551 ATLANTIS TRANSLATIONAL SCREWS AND INSTRUMENT AWL HWJ MEDTRONIC SOFAMOR DANEK USA, INC 7080911 EM10K026 00613994236098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown