BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 15085418 · Received July 22, 2022

    Report

    Report Number
    1030489-2022-00685
    Event Type
    Injury
    Date Received
    July 22, 2022
    Date of Event
    April 1, 2022
    Report Date
    July 22, 2022
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED ARTICLE. PRODUCT IDENTIFIER IS UNKNOWN. IMPLANT DATE WAS NOT AVAILABLE SO DATE RANGE IS ADDED. PRODUCT IDENTIFIER IS UNKNOWN, HENCE 510K# IS NOT AVAILABLE. JOSH E. SCHROEDER, SAADIT HOURI, YORAM A. WEIL, MEIR LIEBERGALL, RAMI MOSHIOF AND LEON KAPLAN WHEN GIANTS TALK; ROBOTIC DIALOG DURING THORACOLUMBAR AND SACRAL SURGERY. 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

    SUMMARY: SPINAL TRAUMA PATIENTS TREATED IN A SPECIALIZED HYBRID OPERATING ROOM (OR) USING TWO ROBOTIC SYSTEMS COMMUNICATING DURING SURGERY. METHODS: RETROSPECTIVE 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 ROBOTICGUIDANCE PLATFORM RENAISSANCE (MAZOR ROBOTICS). RESULTS: 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 RADIATIONEXPOSURE 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) T RAJECTORIES 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. CONCLUSIONS: MERGING OF SURGICAL ROBOTICS TECHNOLOGIES INCREASES PATIENT SAFETY AND SURGEON AND PATIENT CONFIDENCE IN PERCUTANEOUS SPINE TRAUMATIC PROCEDURES. THERE WAS ONE MINOR COMPLICATION IN ONE PATIENT, A LOCAL WOUND INFECTION, TREATED WITH ORAL ANTIBIOTICS. 48 Y/O FEMALE WITH BECHET DISEASE WAS ADMITTED WITH MULTILEVEL OSTEOPOROTIC FX DUE TO PROLONGED STEROID USE. THE PATIENT HAD A PERCUTANEOUS AUGMENTATION L4*2, L3, T9-12 USING ROBOTIC GUIDANCE AND 3D INTRAOPERATIVE IMAGING. THE PATIENT HAD MINIMAL CEMENT EMBOLI AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569922 UNKNOWN CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_BKP_CEMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other