BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAISSANCE SYSTEM

    MDR report key: 8905525 · Received August 19, 2019

    Report

    Report Number
    1723170-2019-04518
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    February 17, 2017
    Report Date
    August 19, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K120812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE OF PUBLICATION OF THE ARTICLE AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. THE REPORTED EVENT WAS FROM THE FOLLOWING LITERATURE ARTICLE: URAKOV T, HSUAN-KAN CHANG K, BURKS S, WANG M. INITIAL ACADEMIC EXPERIENCE AND LEARNING CURVE WITH ROBOTIC SPINE INSTRUMENTATION. NEUROSURGICAL FOCUS. VOLUME 42 (5). DOI: 10.3171/2017.2. FOCUS175. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    ABSTRACT: SPINE SURGERY IS COMPLEX AND INVOLVES VARIOUS STEPS. CURRENT ROBOTIC TECHNOLOGY IS MOSTLY AIMED AT ASSISTING WITH PEDICLE SCREW INSERTION. THIS REPORT EVALUATES THE FEASIBILITY OF ROBOT-ASSISTED PEDICLE INSTRUMENTATION IN AN ACADEMIC ENVIRONMENT WITH THE INVOLVEMENT OF RESIDENTS AND FELLOWS. THE RENAISSANCE GUIDANCE SYSTEM WAS USED TO PLAN AND EXECUTE PEDICLE SCREW PLACEMENT IN OPEN AND PERCUTANEOUS CONSECUTIVE CASES PERFORMED IN THE PERIOD OF DECEMBER 2015 TO DECEMBER 2016. THE DATABASE WAS REVIEWED TO ASSESS THE USABILITY OF THE ROBOT BY NEUROSURGICAL TRAINEES. OUTCOME MEASURES INCLUDED TIME PER SCREW, FLUOROSCOPY TIME, BREACHED SCREWS, AND OTHER COMPLICATIONS. SCREW PLACEMENT WAS ASSESSED IN PATIENTS WITH POSTOPERATIVE CT STUDIES. THE SPEED OF SCREW PLACEMENT AND FLUOROSCOPY TIME WERE COLLECTED AT THE TIME OF SURGERY BY PERSONNEL AFFILIATED WITH THE ROBOT¿S MANUFACTURER. COMPLICATION AND IMAGING DATA WERE REVIEWED RETROSPECTIVELY. A TOTAL OF 306 PEDICLE SCREWS WERE INSERTED IN 30 PATIENTS WITH ROBOT GUIDANCE. THE AVERAGE TIME FOR JUNIOR RESIDENTS WAS 4.4 MIN/SCREW AND FOR SENIOR RESIDENTS AND FELLOWS, 4.02 MIN/SCREW (P = 0.61). AMONG THE RESIDENTS DEDICATED TO SPINE SURGERY, THE AVERAGE SPEED WAS 3.84 MIN/SCREW, WHILE NON-DEDICATED RESIDENTS TOOK 4.5 MIN/SCREW (P = 0.41). EVALUATION OF BREACHED SCREWS REVEALED SOME OF THE PITFALLS IN USING THE ROBOT. NO SIGNIFICANT DIFFERENCE REGARDING THE SPEED OF PEDICLE INSTRUMENTATION WAS DETECTED BETWEEN THE OPERATORS¿ YEARS OF EXPERIENCE OR DEDICATION TO SPINE SURGERY, ALTHOUGH MORE PARTICIPANTS ARE REQUIRED TO INVESTIGATE THIS COMPLETELY. ON THE OTHER HAND, THERE WAS A TREND TOWARD IMPROVED EFFICIENCY WITH MORE CASES PERFORMED. TO THE AUTHORS¿ KNOWLEDGE, THIS IS THE FIRST REPORTED ACADEMIC EXPERIENCE WITH ROBOT-ASSISTED SPINE INSTRUMENTATION. REPORTED EVENTS: ONE PATIENT OPERATED ON USING THE ROBOTIC GUIDANCE SYSTEM DEVELOPED A PULMONARY EMBOLISM ON DAY TWO AFTER SURGERY. TWO PATIENTS EXPERIENCED PROBLEMS WITH WOUND HEALING. ONE OF THE PATIENTS DEVELOPED DEHISCENCE AND PSEUDOMONAS GROWTH IN THE WOUND. ONE PATIENT EXPERIENCED A FALL AFTER DISCHARGE FROM THE HOSPITAL AND REQUIRED BURR HOLES FOR EVACUATION OF A SUBDURAL HEMATOMA. TWO PATIENTS WITH L1-4 AND L2-S1 INSTRUMENTATION REQUIRED ADDITIONAL SURGERIES TO EXTEND THE CONSTRUCTS DUE TO DEVELOPMENT OF PROXIMAL JUNCTIONAL KYPHOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701251 RENAISSANCE SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC TPL0038

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R