BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    100MM, STERILE, PERC REF

    MDR report key: 19877795 · Received July 31, 2024

    Report

    Report Number
    1723170-2024-01895
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Date of Event
    July 8, 2024
    Report Date
    July 31, 2024
    Manufacturer
    MEDTRONIC INC
    Product Code
    OLO
    PMA / PMN Number
    K131425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 9735665 (SERIAL: ASSET PENDING - S8 P); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 9735670 (SERIAL: (B)(6)); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 9733235 (LOT: 231107); PRODUCT TYPE: 2543-MNAV - SYSTEM; IMPLANT DATE N/A; EXPLANT DATE N/A H3) THE DEVICE WAS RETURNED FOR ANALYSIS. FUNCTIONAL TESTING DETERMINED THAT THE DEVICE WAS FUNCTIONING AS DESIGNED. 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

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE PERC PIN THEY HAD FOR A CASE WAS TO THICK TO FIT IN THE RECEIVER OF THE PERC PIN FRAME. TRIED TO PUT THE PIN INTO THE FRAME RECEIVER AND IT WAS TOO TIGHT SO THEY SWITCHED TO ANOTHER PIN WHICH WAS ABLE TO FIT WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983686 100MM, STERILE, PERC REF ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC INC 9733235 231228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11...