BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UCSS

    MDR report key: 19178217 · Received April 25, 2024

    Report

    Report Number
    1030489-2024-00334
    Event Type
    Malfunction
    Date Received
    April 25, 2024
    Date of Event
    April 8, 2024
    Report Date
    June 5, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    UDI-DI
    00673978067728
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION E: INITIAL REPORTER DETAILS UNKNOWN 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.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS PART# 873-009 ; LOT# BA000187- VISUAL AND OPTICAL INSPECTION CONFIRMED THAT THE HEX OF THE DRIVER HAS BEEN STRIPPED DUE TO TORSIONAL OVERLOAD. H6: UPDATED EVAL. CODE METHOD AND EVAL. CODE RESULT POST ANALYSIS UPDATED ANNEX F CODE POST ANALYSIS 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 MEDTRONIC REPRESENTATIVE REGARDING A DRIVER NOTICED DURING SERVICING AND CLEANING UP. IT WAS REPORTED THAT THE DRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVED IN THE EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161706 UCSS SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC 873-009 BA000187 00673978067728

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown