BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS TRANSLATIONAL SCREWS AND INSTR

    MDR report key: 21382914 · Received February 14, 2025

    Report

    Report Number
    1030489-2025-00781
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    February 16, 2023
    Report Date
    February 14, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART# 7080930, LOT# IM10L025 - VISUAL AND OPTICAL EXAMINATION CONFIRMED THE CORNERS OF THE TORX ON THE TIP OF THE SCREWDRIVER ARE ROUNDED FROM WHAT APPEARS TO BE REPEATED NORMAL USE. THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATED USE OVERTIME. 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 PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING UNKNOWN SPI NAL SURGERY. IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN DURING THE PROCEDURE. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204927 ATLANTIS TRANSLATIONAL SCREWS AND INSTR ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC 7080930 IM10L025

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown