BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 18211315 · Received November 27, 2023

    Report

    Report Number
    3004785967-2023-00711
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    August 8, 2023
    Report Date
    November 27, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE ACCEPTED DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. 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

    GILANI, S., MOHAMED, M., HARTLEY, B., ZAMORA, R., ZOU, J., DACCARETT, M., CARLSON, J.B. THE USE OF A ROBOTIC ARM FOR FIXATION OF PELVIC FRACTURES. JOURNAL OF ORTHOPEDIC TRAUMA. 2023. 37 (S28¿S32) DOI: 10.1097/BOT.0000000000002691. OBJECTIVES: THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE UNPLANNED CORTICAL OR NEUROFORAMINAL VIOLATION OF ILIOSACRAL AND TRANSSACRAL SCREW PLACEMENT USING FLUOROSCOPY VERSUS SCREW PLACEMENT USING A ROBOTIC ARM. DESIGN: THIS IS A PROSPECTIVE COHORT STUDY. SETTING: SINGLE SURGEON, SINGLE NORTH AMERICAN LEVEL 1 TRAUMA CENTER. PATIENTS: RADIOGRAPHIC AND CLINICAL DATA FOR 21 CONSECUTIVE ADULT TRAUMA PATIENTS WITH PELVIC RING FRACTURES UNDERGOING SURGICAL TREATMENT WERE PROSPECTIVELY COLLECTED. TREATMENT CONSISTED OF ILIOSACRAL AND/OR TRANSSACRAL SCREWS WITH OR WITHOUT ANTERIOR FIXATION. INTERVENTION: TEN PATIENTS WERE TREATED WITH THE ASSISTANCE OF A ROBOTIC ARM. ELEVEN PATIENTS WERE TREATED WITH STANDARD FLUORO-SCOPIC TECHNIQUES. MAIN OUTCOME MEASUREMENTS: THIRTY-TWO SCREWS WERE PLACED AND EVALUATED WITH POSTOPERATIVE COMPUTED TOMOGRAPHY OR O-ARM SPINS TO ASSESS UNPLANNED CORTICAL OR NEUROFORAMINAL VIOLATION. VIOLATIONS WERE GRADED ACCORDING TO THE GERTZBEIN AND ROBBINS SYSTEM FOR PEDICLE SCREW VIOLATION, CATEGORIZING SCREW VIOLATION IN 2-MM INCREMENTS. THE POSTOPERATIVE IMAGES WERE BLINDLY REVIEWED BY 5 FELLOWSHIP-TRAINED ORTHOPAEDIC TRAUMATOLOGISTS. THE TREATING SURGEON WAS EXCLUDED FROM REVIEW. RESULTS: THE MANN¿WHITNEY U TEST ON THE GERTZBEIN AND ROBBINS SYSTEM RESULTS DEMONSTRATED SIGNIFICANTLY (P = 0.02) FEWER VIOLATIONS WITH ROBOTIC ASSISTANCE. X2 ANALYSIS OF WHETHER THERE WAS A CORTICAL VIOLATION OF ANY DISTANCE DEMONSTRATED SIGNIFICANTLY (P = 0.003) FEWER CORTICAL VIOLATIONS WITH ROBOTIC ASSISTANCE. THERE WERE NO NEU-ROVASCULAR INJURIES IN EITHER GROUP. CONCLUSION: ROBOTIC ASSISTANCE DEMONSTRATED SIGNIFICANTLY FEWER UNPLANNED CORTICAL OR NEUROFORAMINAL VIOLATIONS. FURTHER RESEARCH IS NEEDED WITH ADDITIONAL SURGEONS AND SITES TO EVALUATE THE ACCURACY OF ILIOSACRAL AND TRANSSACRAL SCREW PLACEMENT WITH ROBOTIC ASSISTANCE. REPORTED EVENTS 24 VIOLATIONS WERE NOTED ACROSS ALL CASES SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219492 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC (LITTLETON) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female