BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METRX SYSTEM

    MDR report key: 19114140 · Received April 16, 2024

    Report

    Report Number
    1030489-2024-00275
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    November 20, 2023
    Report Date
    April 16, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    LXH
    UDI-DI
    00721902320019
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS #(B)(4):PART # 9561428: LOT# K22K1351 VISUAL AND OPTICAL INSPECTION CONFIRMED THE EDGES, AND THE INNER SURFACE OF THE DILATOR ARE WORN. THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATED USE AND CLEANING. 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN E VENT. IT WAS REPORTED THAT EACH DILATOR HAD A BROWN, RUST LIKE, RESIDUE THAT WAS LEFT ON THE SWAB. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690741 METRX SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH MEDTRONIC SOFAMOR DANEK USA, INC 9561428 K22K1351 00721902320019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown