BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXO

    MDR report key: 8326505 · Received February 11, 2019

    Report

    Report Number
    3004785967-2019-00221
    Event Type
    Malfunction
    Date Received
    February 11, 2019
    Date of Event
    February 1, 2019
    Report Date
    February 28, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OWB
    UDI-DI
    00643169639683
    PMA / PMN Number
    K151000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS #702988341:EXTERNAL REFERENCE ID : (B)(4) AUTHOR/DATE/SUBJECT/NOTE: MARK HALL / 2019-02-01 / WORK ORDER (B)(4) / WORK ORDER (B)(4) AUTHOR/DATE/SUBJECT/NOTE: MARK HALL / 2019-02-01 / WORK ORDER (B)(4) / WORK ORDER (B)(4) AUTHOR/DATE/SUBJECT/NOTE: MARK HALL / 2019-02-01 / AUTO CREATED FROM WORK ORDER (B)(4) / RECORD TYPE UPDATED FROM O-ARM SYSTEM CHECKOUT TO O-ARM SYSTEM CHECKOUT (CLOSED) AUTHOR/DATE/SUBJECT/NOTE: MARK HALL / 2019-02-01 / WORK ORDER (B)(4) ADDED TO COMPLAINT / STATUS: COMPLETED DATE COMPLETED: 2019-02-01 MECHANICAL TESTS: PASS IMAGING MODALITIES: PASS CABLE GRADE: A RECORD TYPE: O-ARM SYSTEM CHECKOUT CONTACT: YADIM DAVID SYSTEM INSPECTION: PASS DOES THE SYSTEM PERFORM AS INTENDED?: YES WERE HARDWARE PARTS REPLACED?: NO ACTION/RESOLUTION: GENERATOR NOT READY ERROR 32. RESEATED GENERATOR LICENSE DONGLE PER SERVICE DOCUMENTATION AND PROBLEM WAS RESOLVED. AUTHOR/DATE/SUBJECT/NOTE: MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    2019-02-01 00657238 (REP HCP): MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED FOR A SPINAL FUSION PROCEDURE. IT WAS REPORTED THAT THE SITE WAS ABLE TO TAKE A COUPLE 2D IMAGES AND A 3D SCAN, BUT WHEN THEY RETURNED TO 2D TO TAKE ADDITIONAL IMAGES, THERE WAS A RED X ON THE GENERATOR. THE SITE REBOOTED WITHOUT RESOLVE. THEY SWITCHED TO A DIFFERENT MEDTRONIC IMAGING SYSTEM AND PROCEEDED WITH THE CASE. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME.

    Additional Manufacturer Narrative · 1

    ONSITE FUNCTIONAL AND VISUAL EXAMINATION WAS PERFORMED BY A MANUFACTURER REPRESENTATIVE. THE DONGLE WAS FOUND TO BE UNSEATED. THE REPRESENTATIVE RESEATED THE DONGLE AND THE ISSUE WAS RESOLVE. THE SYSTEM PASSED A SYSTEM CHECKOUT AND WAS RETURNED TO AN OPERATIONAL CONDITION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING DEVICE BEING USED FOR A SPINAL FUSION PROCEDURE. IT WAS REPORTED THAT THE SITE WAS ABLE TO TAKE A COUPLE 2D IMAGES AND A 3D SCAN, BUT WHEN THEY RETURNED TO 2D TO TAKE ADDITIONAL IMAGES, THERE WAS A RED X ON THE GENERATOR. THE SITE REBOOTED WITHOUT RESOLVE. THEY SWITCHED TO A DIFFERENT MEDTRONIC IMAGING SYSTEM AND PROCEEDED WITH THE CASE. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122858 OXO INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB MEDTRONIC NAVIGATION, INC (LITTLETON) BI70002000 00643169639683

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR