BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY

    MDR report key: 19790205 · Received July 22, 2024

    Report

    Report Number
    1030489-2024-00869
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    April 25, 2024
    Report Date
    July 22, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    E: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. H3: PRODUCT ANALYSIS OF PART # 3606195, LOT # K23G1051 VISUAL AND OPTICAL INSPECTION REVEALED SOME DEFORMATION AROUND THE PERIMETER OF THE PIN THROUGH HOLE. THE PIN WAS NOT RETURNED FOR A NALYSIS. THE DAMAGE APPEARS TO BE FROM TORSIONAL OVERLOAD AND NOT PROPERLY SEATING THE DRIVER IN THE SCREW HEAD. 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 USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT WHEN PUTTING THE TRAYS TOGETHER IT WAS IDENTIFIED THAT THE PIN HAD FALLEN OUT DURING WASH AND DRIVER IS NO UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119166 INFINITY APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC 3606195 K23G1051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown