BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAISSANCE SYSTEM

    MDR report key: 8904446 · Received August 18, 2019

    Report

    Report Number
    1723170-2019-04514
    Event Type
    Injury
    Date Received
    August 18, 2019
    Date of Event
    June 9, 2016
    Report Date
    August 18, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K120812
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: KERIC N, EUM D, AFGHANYAR F, RACHWAL-CZYZEWICZ I, RENOVANZ M, CONRAD J, WEP D, KANTELHARDT S, GIESE A. EVALUATION OF SURGICAL STRATEGY OF CONVENTIONAL VS. PERCUTANEOUS ROBOT-ASSISTED SPINAL TRANS-PEDICULAR INSTRUMENTATION IN SPONDYLODISCITIS. JOURNAL OF ROBOTIC SURGERY. DOI: 10.1007/S11701-016-0597-5. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ABSTRACT: ROBOT-ASSISTED PERCUTANEOUS INSERTION OF PEDICLE SCREWS IS A RECENT TECHNIQUE DEMONSTRATING HIGH ACCURACY. THE OPTIMAL TREATMENT FOR SPONDYLODISCITIS IS STILL A MATTER OF DEBATE. WE PERFORMED A RETROSPECTIVE COHORT STUDY ON SURGICAL PATIENTS TREATED WITH PEDICLE SCREW/ROD PLACEMENT ALONE WITHOUT THE APPLICATION OF INTERVERTEBRAL CAGES. IN THIS COLLECTIVE, WE COMPARE CONVENTIONAL OPEN TO A FURTHER MINIMALIZED PERCUTANEOUS ROBOT-ASSISTED SPINAL INSTRUMENTATION, AVOIDING A DIRECT CONTACT OF IMPLANTS AND INFECTIOUS FOCUS. 90 RECORDS AND CT SCANS OF PATIENTS TREATED BY DORSAL TRANSPEDICULAR INSTRUMENTATION OF THE INFECTED SEGMENTS WITH AND WITHOUT DECOMPRESSION AND ANTIBIOTIC THERAPY WERE ANALYSED FOR CLINICAL AND RADIOLOGICAL OUTCOME PARAMETERS. 24 PATIENTS WERE TREATED BY FREE-HAND FLUOROSCOPY-GUIDED SURGERY (121 SCREWS), AND 66 PATIENTS WERE TREATED BY PERCUTANEOUS ROBOT-ASSISTED SPINAL INSTRUMENTATION (341 SCREWS). ACCURATE SCREW PLACEMENT WAS CONFIRMED IN 90 % OF ROBOT-ASSISTED AND 73.5 % OF FREE-HAND PLACED SCREWS. IMPLANT REVISION DUE TO MISPLACEMENT WAS NECESSARY IN 4.95 % OF THE FREE-HAND GROUP COMPARED TO 0.58 % IN THE ROBOT-ASSISTED GROUP. THE AVERAGE INTRAOPERATIVE X-RAY EXPOSURE PER CASE WAS 0.94 ± 1.04 MIN IN THE FREEHAND GROUP VS. 0.4 ± 0.16 MIN IN THE PERCUTANEOUS GROUP (P = 0. 000). INTRAOPERATIVE ADVERSE EVENTS WERE OBSERVED IN 12.5 % OF FREE-HAND PLACED PEDICLE SCREWS AND 6.1 % OF ROBOT ROBOT-ASSISTED SCREWS. THE MEAN POSTOPERATIVE HOSPITAL STAY IN THE FREE-HAND GROUP WAS 18.1 ± 12.9 DAYS, AND IN PERCUTANEOUS GROUP, 13.8 ± 5.6 DAYS (P = 0.012). THIS STUDY DEMONSTRATES THAT THE ROBOT-GUIDED INSERTION OF PEDICLE SCREWS IS A SAFE AND EFFECTIVE PROCEDURE IN LUMBAR AND THORACIC SPONDYLODISCITIS WITH HIGHER ACCURACY OF IMPLANT PLACEMENT, LOWER RADIATION DOSE, AND DECREASED COMPLICATION RATES. PERCUTANEOUS SPINAL DORSAL INSTRUMENTATION SEEMS TO BE SUFFICIENT TO TREAT LUMBAR AND THORACIC SPONDYLODISCITIS. REPORTED EVENTS: 4 PATIENTS BEING TREATED FOR SPONDYLODISCITIS USING THE ROBOTIC GUIDANCE SYSTEM EXPERIENCED WOUND HEALING ABNORMALITIES AND INFECTION. ALL OF THE PATIENTS REQUIRED A REVISION SURGERY. 2 PATIENTS BEING TREATED FOR SPONDYLODISCITIS USING THE ROBOTIC GUIDANCE SYSTEM HAD TO HAVE A REVISION DUE TO MISPLACED SCREWS. 4 PATIENTS BEING TREATED FOR SPONDYLODISCITIS USING THE ROBOTIC GUIDANCE SYSTEM HAD TO HAVE A REVISION DUE TO LOOSENED SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698070 RENAISSANCE SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC TPL0038

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention