BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM 1000 IMAGING SYSTEM

    MDR report key: 13578180 · Received February 22, 2022

    Report

    Report Number
    3004785967-2022-00122
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    December 2, 2021
    Report Date
    May 24, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    PMA / PMN Number
    K050996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT SEX NOT AVAILABLE FROM THE SITE. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ACCEPTED DATE OF THE PUBLICATION. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURE DATE IS DEPENDENT ON THE DEVICE LOT/SERIAL NUMBER, THEREFORE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    H2) ADDITIONAL INFORMATION: SEE SECTION B5 AND SECTION D MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED 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. 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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

    CITATION: TOMOHISA INOUE, KEIJI WADA, AYAKO TOMINAGA, RYO TAMAKI, TOMOYA HIROTA, KEN OKAZAKI. O-ARM ASSISTED CERVICOTHORACIC SPINE PEDICLE SCREW PLACEMENT ACCURACY IS HIGHER THAN C-ARM FLUOROSCOPY. WORLD NEUROSURGERY (2021). HTTPS://DOI.ORG/10.1016/J.WNEU.2021.12.006 ABSTRACT: - OBJECTIVE: WE COMPARED THE ACCURACY OF C-ARM FLUOROSCOPY VERSUS O-ARMLASSISTED PEDICLE SCREW (PS) PLACEMENT IN THE CERVICOTHORACIC SPINAL JUNCTION (CTSJ). - METHODS: PATIENTS WHO UNDERWENT PS PLACEMENT IN THE CTSJ (C7-T4) AT OUR HOSPITAL WERE INCLUDED IN THIS STUDY. OF 37 PATIENTS WHO UNDERWENT PS PLACEMENT IN THE CTSJ, 20 UNDERWENT INTRAOPERATIVE C-ARM FLUOROSCOPY-ASSISTED SURGERY (C GROUP) AND 17 UNDERWENT INTRAOPERATIVE O-ARM ASSISTED SURGERY (O GROUP). IN TOTAL, 159 PSS WERE PLACED¿ 73 IN THE C GROUP AND 86 IN THE O GROUP. THE ACCURACY OF PS PLACEMENT WAS COMPARED BETWEEN THE C GROUP AND O GROUP USING THE CLASSIFICATION PROPOSED BY GERTZBEIN AND ROBBINS TO ANALYZE PEDICLE VIOLATION. - RESULTS: PS ACCURACY WAS HIGHER IN THE O GROUP THAN C GROUP; PS PLACEMENT EVALUATED AS GRADE A, REPRESENTING NO PERFORATION, WAS 95.3% (82/86) FOR THE O GROUP, WHEREAS IT WAS 78.1% (57/73) FOR THE C GROUP. THERE WAS A CLEAR STATISTICALLY SIGNIFICANT DIFFERENCE IN ACCURACY OF PS PLACEMENT BETWEEN THE GROUPS (P [ 0.0013). - CONCLUSIONS: O-ARMLASSISTED SURGERY IMPROVED THE ACCURACY OF PS PLACEMENT IN THE CTSJ. REPORTED EVENTS: 4 SCREWS WERE REPORTED TO HAVE BEEN PLACED WITH A GRADE B PERFORATION 3 SCREWS WERE REPORTED TO HAVE BEEN PLACED WITH A GRADE D PERFORATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THERE WAS NO ALLEGATION OF A MALFUNCTION BY THE SYSTEMS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905217 O-ARM 1000 IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC (LITTLETON) 9732719

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown