BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINEASSIST SYSTEM

    MDR report key: 8906142 · Received August 19, 2019

    Report

    Report Number
    1723170-2019-04524
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    March 8, 2011
    Report Date
    August 19, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K073467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: KANTELHARDT S, MARTINEZ R, BAERWINKEL S, BURGER R, GIESE A, ROHDE V. PERIOPERATIVE COURSE AND ACCURACY OF SCREW POSITIONING IN CONVENTIONAL, OPEN ROBOTIC-GUIDED AND PERCUTANEOUS ROBOTIC-GUIDED, PEDICLE SCREW PLACEMENT. EUROPEAN SPINE JOURNAL. 2011. DOI 10.1007/S00586-011-1729-2. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    ABSTRACT: ROBOTIC-GUIDED AND PERCUTANEOUS PEDICLE SCREW PLACEMENT ARE EMERGING TECHNOLOGIES. WE HERE REPORT A RETROSPECTIVE COHORT ANALYSIS COMPARING CONVENTIONAL OPEN TO OPEN ROBOTIC-GUIDED AND PERCUTANEOUS ROBOTIC-GUIDED PEDICLE SCREW PLACEMENT. 112 PATIENT RECORDS AND CT SCANS WERE ANALYZED CONCERNING THE INTRAOPERATIVE AND PERIOPERATIVE COURSE. 35 PATIENTS UNDERWENT PERCUTANEOUS, 20 OPEN ROBOTIC GUIDED AND 57 OPEN CONVENTIONAL PEDICLE SCREW PLACEMENT. 94.5% OF ROBOT-ASSISTED AND 91.4% OF CONVENTIONALLY PLACED SCREWS WERE FOUND TO BE ACCURATE. PERCUTANEOUS ROBOTIC AND OPEN ROBOTIC-GUIDED SUBGROUPS DID NOT DIFFER OBVIOUSLY. AVERAGE X-RAY EXPOSURE PER SCREW WAS 34 S IN ROBOTIC-GUIDED COMPARED TO 77 S IN CONVENTIONAL CASES. SUBGROUP ANALYSIS INDICATES THAT PERCUTANEOUSLY OPERATED PATIENTS REQUIRED LESS OPIOIDS, HAD A SHORTER HOSPITALIZATION AND LOWER RATE OF ADVERSE EVENTS IN THE PERIOPERATIVE PERIOD. THE USE OF ROBOTIC GUIDANCE SIGNIFICANTLY INCREASED ACCURACY OF SCREW POSITIONING WHILE REDUCING THE X-RAY EXPOSURE. PATIENTS SEEM TO HAVE A BETTER PERIOPERATIVE COURSE FOLLOWING PERCUTANEOUS PROCEDURES. REPORTED EVENTS: ONE MAJOR HEMORRHAGE WAS OBSERVED INTRAOPERATIVELY IN PROCEDURES USING THE ROBOTIC GUIDANCE SYSTEM. SIX DURAL TEARS WERE OBSERVED INTRAOPERATIVELY IN PROCEDURES USING THE ROBOTIC GUIDANCE SYSTEM. ONE INFECTION WAS OBSERVED POSTOPERATIVELY AFTER A PROCEDURE USING THE ROBOTIC GUIDANCE SYSTEM. 8 PATIENTS UNDERGOING PROCEDURES USING THE ROBOTIC GUIDANCE SYSTEM REQUIRED REVISIONS DUE TO MISPLACED SCREWS. 5 PATIENTS UNDERGOING PROCEDURES USING THE ROBOTIC GUIDANCE SYSTEM REQUIRED SECONDARY SUTURES UNDER LOCAL ANESTHESIA TO BE PLACED BECAUSE OF WOUND HEALING DISORDERS AND INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698976 SPINEASSIST SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC TPL0001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention