BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAISSANCE SYSTEM

    MDR report key: 18491742 · Received January 11, 2024

    Report

    Report Number
    9616637-2024-00001
    Event Type
    Injury
    Date Received
    January 11, 2024
    Date of Event
    June 13, 2023
    Report Date
    January 11, 2024
    Manufacturer
    VISIONSENSE LTD.
    Product Code
    HAW
    PMA / PMN Number
    K152041
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.1-A.5) PATIENT INFORMATION WAS INCLUDED IN THE JOURNAL. A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.4. THE PATIENT'S WEIGHT WAS NO PROVIDED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED ONLINE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B5 INCLUDED THE ARTICLE CITATION D.4. THE SYSTEM SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. H.3. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H.4. DEVICE MANUFACTURING DATE WAS UNAVAILABLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    BETTAG, C., JANN, T., ROHDE, V., FISS, I., SCHATLO, B., VON DER BRELIE, C. (2023). ROBOT-ASSISTED SPINAL AUGMENTATION PROCEDURES: IS IT WORTH THE INCREASED EFFORT? EUROPEAN SPINE JOURNAL, 32(11), 3927¿3932. HTTPS://DOI.ORG/10.1007/S00586-023-07735-Z PURPOSE:SPINAL AUGMENTATION PROCEDURES (SAP) ARE STANDARD PROCEDURES FOR VERTEBRAL COMPRESSION FRACTURES. OFTEN, SAPS ARE CARRIED OUT IN A MINIMALLY INVASIVE, PERCUTANEOUS WAY. CERTAIN ANATOMIC CONDITIONS SUCH AS SMALL PEDICLES OR KYPHOTIC DEFORMITIES RESULTING FROM A SIGNIFICANT COLLAPSE OF THE VERTEBRAL BODY MIGHT RENDER THE OPERATION MORE DIFFICULT AND INCREASE THE RISK OF COMPLICATIONS. THUS, ROBOT ASSISTANCE MIGHT BE USEFUL TO OPTIMIZE THE TRAJECTORY AND TO REDUCE PROCEDURE-ASSOCIATED COMPLICATIONS. IN THIS STUDY ROBOT-ASSISTED PERCUTANEOUS SAPS ARE COMPARED WITH CONVENTIONAL FLUOROSCOPY-GUIDED PERCUTANEOUS SAP. METHODS: A RETROSPECTIVE OBSERVATIONAL ANALYSIS WAS CARRIED OUT. STANDARD DEMOGRAPHIC PARAMETERS WERE ANALYZED. PROCEDURAL DATA INCLUDING RADIATION DOSAGE RECORDS WERE SCREENED. BIOMECHANICAL DATA WERE RECORDED. CEMENT VOLUMES WERE ANALYZED. THE PRECISION OF THE PEDICULAR TRAJECTORY WAS REVIEWED, AND MISPLACED TRAJECTORIES WERE CATEGORIZED. PROCEDURE ASSOCIATED COMPLICATIONS WERE ANALYZED AND EVALUATED FOR THEIR CLINICAL SIGNIFICANCE. RESULTS: A TOTAL OF 130 PROCEDURES WERE REVIEWED, AND 94 PATIENTS WERE FINALLY INCLUDED. OSTEOPOROTIC FRACTURES (OF) WERE THE MAIN INDICATION (60.7%; OF 2¿44%, OF 4¿33%). DEMOGRAPHIC PARAMETERS AND CLINICALLY RELEVANT COMPLICATIONS WERE EQUALLY DISTRIBUTED BETWEEN THE TWO GROUPS. DURATION OF SURGERY WAS SIGNIFICANTLY LONGER IN ROBOT-ASSISTED PROCEDURES (P 0.001). INTRAOPERATIVE RADIATION EXPOSURE WAS EQUALLY DISTRIBUTED. INJECTED CEMENT VOLUME WAS SIMILAR IN BOTH GROUPS. THERE WAS NO SIGNIFICANT DIFFERENCE IN PEDICLE TRAJECTORY DEVIATION. CONCLUSION: THE USE OF ROBOT ASSISTANCE IN SAP SEEMS NOT TO BE SUPERIOR WITH REGARD TO ACCURACY, RADIATION EXPOSURE AND THE RATE OF COMPLICATIONS WHEN COMPARED TO FLUOROSCOPY-GUIDED SAP. REPORTED EVENTS SEVENTY PATIENTS UNDERWENT SPINAL AUGMENTATION PROCEDURES TO ADDRESS VERTEBRAL COMPRESSION FRACTURES. OF THESE PATIENTS, THERE WERE TWELVE COMPLICATIONS. TWO COMPLICATIONS WERE DUE TO CEMENT LEAKAGE, TWO WERE DUE TO A MISPLACED PUNCTURE, AND FIVE WERE COMPLICATIONS WITH THE THORACIC SPINE. THREE COMPLICATIONS REQUIRED PHARMACOLOGICAL TREATMENT WITH DRUGS. FOUR COMPLICATIONS REQUIRED SURGICAL, ENDOSCOPIC, OR RADIOLOGICAL INTERVENTION, ONE UNDER LOCAL ANESTHESIA AND THREE UNDER GENERAL ANESTHESIA. FINALLY, IT WAS NOTED THAT TWO TRAJECTORIES WERE INACCURATE BY LESS THAN TWO MILLIMETER, FOUR WERE BETWEEN TWO AND FOUR MILLIMETERS, AND FOUR WERE BETWEEN FOUR AND SIX MILLIMETERS INACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003432 RENAISSANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW VISIONSENSE LTD. TPL0038

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention