BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAISSANCE SYSTEM

    MDR report key: 14427794 · Received May 18, 2022

    Report

    Report Number
    3005075696-2022-00044
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    April 1, 2022
    Report Date
    May 17, 2022
    Manufacturer
    MAZOR ROBOTICS LTD
    Product Code
    HAW
    PMA / PMN Number
    K152041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: SCHROEDER J, HOURI S, WEIL Y, LIEBERGALL M, MOSHIOFF R, KAPLAN L. WHEN GIANTS TALK; ROBOTIC DIALOG DURING THORACOLUMBAR AND SACRAL SURGERY. BMC SURGERY. (2022) 22:125. HTTPS://DOI.ORG/10.1186/S12893-022-01546-7. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ABSTRACT: SPINAL TRAUMA PATIENTS TREATED IN A SPECIALIZED HYBRID OPERATING ROOM (OR) USING TWO ROBOTIC SYSTEMS COMMUNICATING DURING SURGERY. R ETROSPECTIVE REVIEW OF PATIENTS WITH THORACOLUMBAR OR SACRAL FRACTURES WHO UNDERWENT SURGICAL FIXATION BETWEEN JAN 2017 TO JAN 2020 WITH ROBOTIC-GUIDED PERCUTANEOUS PEDICLE SCREW INSERTION IN THE SPECIALIZED HYBRID OR WITH ROBOTIC FLAT PANEL 3D C-ARM (ARTISZEEGO) FOR INTRAOPERATIVE INTERVENTIONAL IMAGING CONNECTED WITH THE ROBOTIC GUIDANCE PLATFORM RENAISSANCE (MAZOR ROBOTICS). TWENTY EIGHT SURGERIES WERE PERFORMED IN 27 PATIENTS; 23 WITH TRAUMATIC SPINAL FRACTURES, 4 WITH MULTI-LEVEL THORACOLUMBAR COMPRESSION FRACTURES DUE TO SEVERE OSTEOPOROSIS. AVERAGE PATIENT AGE 49 (RANGE 12¿86). AVERAGE RADIATION EXPOSURE TIME 40 S (RANGE 12¿114 S). AVERAGE RADIATION EXPOSURE DOSE 11 ,584 ± SD UGYM2 (RANGE 4454¿58,959). LUMBER LEVELS OPERATED ON WERE BETWEEN T5 AND S2 (SHORTEST THREE VERTEBRAS AND LONGEST EIGHT VERTEBRAS). 235 (RANGE 5¿11) TRAJECTORIES WERE PERFORMED. ALL TRAJECTORIES WERE ACCURATE IN ALL CASES PERCUTANEOUS PEDICLE SCREWS PLACEMENT WAS CORRECT, WITHOUT BREACH NOTED AT THE PEDICLE IN ANY OF THE CASES. NO MAJOR COMPLICATIONS REPORTED. IN ALL CASES, FOLLOW-UP X-RAYS SHOWED ADEQUATE FRACTURE REDUCTION WITH RESTORATION. MERGING OF SURGICAL ROBOTICS TECHNOLOGIES INCREASES PATIENT SAFETY AND SURGEON AND PATIENT CONFIDENCE IN PERCUTANEOUS SPINE TRAUMATIC PROCEDURES. REPORTED EVENT THERE WAS ONE MINOR COMPLICATION IN ONE PATIENT, A LOCAL WOUND INFECTION, TREATED WITH ORAL ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851168 RENAISSANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MAZOR ROBOTICS LTD TPL0038

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention