BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 15239368 · Received August 17, 2022

    Report

    Report Number
    1030489-2022-00781
    Event Type
    Injury
    Date Received
    August 17, 2022
    Date of Event
    March 31, 2022
    Report Date
    August 17, 2022
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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: 67 YEARS (RANGE, 45-87 YEARS). THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED: 19 WOMEN AND 22 MEN. OUTCOMES ATTRIBUTED TO ADVERSE EVENT: PULMONARY EMBOLISM. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. REPORT SOURCE: COUNTRY: TURKEY, NILGUN SENOL, ALI SERDAR OGUZOGLU, HAKAN MURAT GOKSEL "RADIOFREQUENCY ABLATION AND AUGMENTATION IN THE MANAGEMENT OF SPINAL METASTASES: CLINICAL EXPERIENCE IN 41 PATIENTS" WORLD NEUROSURGERY (2022) 163:E420-E425. DOI.ORG/10.1016/J.WNEU.2022.03.140. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    NILGUN SENOL, ALI SERDAR OGUZOGLU, HAKAN MURAT GOKSEL "RADIOFREQUENCY ABLATION AND AUGMENTATION IN THE MANAGEMENT OF SPINAL METASTASES: CLINICAL EXPERIENCE IN 41 PATIENTS" WORLD NEUROSURGERY (2022) 163:E420-E425. DOI.ORG/10.1016/J.WNEU.2022.03.140. SUMMARY: EVALUATION OF FUNCTIONAL OUTCOME AFTER COMBINED RADIOFREQUENCY ABLATION AND VERTEBRAL AUGMENTATION IN PATIENTS WITH METASTATIC SPINAL TUMORS USING VISUAL ANALOG SCALE AND OSWESTRY DISABILITY INDEX SCORES. VISUAL ANALOG SCALE AND OSWESTRY DISABILITY INDEX WERE USED TO ASSESS THE INTENSITY OF PAIN AND QUALITY OF LIFE. THE ASSESSMENTS WERE PERFORMED BEFORE THE PROCEDURE AND AT 1 WEEK AND 1, 2, 3, AND 6 MONTHS AFTER THE PROCEDURE. REPORTED EVENTS: 1. THIS RETROSPECTIVE STUDY INCLUDED 41 PATIENTS WITH METASTATIC SPINAL TUMORS, ANALYZED FROM JANUARY 2018 TO FEBRUARY 2019.. THERE WERE 19 WOMEN AND 22 MEN WITH A MEAN AGE OF 67 YEARS (RANGE, 45E87 YEARS). ALL PATIENTS PRESENTED WITH SPINAL PAIN SECONDARY TO METASTATIC CANCER INVOLVEMENT OF THE SPINAL COLUMN WITH OR WITHOUT SYSTEMIC CANCERDISEASE. 2. THE TREATMENT PROCEDURE WAS PERFORMED UNDER SEDATION WITH FENTANYL AND MIDAZOLAM. AFTER PRONE POSITIONING OF THE PATIENTS, THE TARGET SPINAL SEGMENT WAS DEFINED WITH FLUOROSCOPIC IMAGING. AFTER STERILE PREPARATION AND DRAPING, LOCAL ANESTHESIA (1% LIDOCAINE) WAS USED AT THE ACCESS OF THE TARGETED VERTEBRA. THE VERTEBRAL BODY WAS ACCESSED VIA A TRANSPEDICULAR APPROACH WITH A 10-GAUGE INTRODUCER CANNULA. A NAVIGATIONAL OSTEOTOME WAS USED TO CONSTITUTE AN OSSEOUS CHANNEL. TISSUE SAMPLES WERE OBTAINED WITH SUITABLE NEEDLE ASPIRATION OR CURETTAGE IN ALL SPINAL LEVELS. 3. THE AIM WAS TO ABLATE THE ENTIRE VOLUME OF THE ENHANCED BONE TISSUE ACCORDING TO THE T2 HYPERINTENSITY AND ENHANCEMENT ON MAGNETIC RESONANCE IMAGING. 4. THE UNIPEDICULAR APPROACH WAS USED FOR 36 PATIENTS, AND THE BIPEDICULAR APPROACH WAS USED FOR 5 PATIENTS. THE ABLATION PROBE WAS INSERTED. THE TARGET TEMPERATURE OF 80 DEGREE C WAS OBTAINED FOR 2 MINUTES. 5. AFTER ABLATION, THE VERTEBRAL AUGMENTATION PROCEDURE WAS PERFORMED. THE ELECTRODE NEEDLE WAS WITHDRAWN, AND POLYMETHYL METHACRYLATE WAS INJECTED INTO THE ABLATED CAVITY UNDER FLUOROSCOPIC GUIDANCE IN BOTH ANTEROPOSTERIOR AND LATERAL PROJECTIONS. THROUGH A WORKING CANNULA, 3E5 ML OF BONE CEMENT WAS INJECTED TO FILL THE ABLATED CAVITY ACCORDING TO THE LEVEL. AFTER THE PROCEDURE, ALL PATIENTS UNDERWENT EARLY IMAGING WITH COMPUTED TOMOGRAPHY. 6. ALL PREPROCEDURAL AND POSTPROCEDURAL VAS AND ODI SCORES WERE ANALYZED BY MULTIVARIATE TESTS AT EACH FOLLOW-UP POINT TO EVALUATE THE CHANGE IN PAIN AND FUNCTIONAL STATUS. 7. NO SERIOUS COMPLICATIONS WERE SEEN IN THE PERIPROCEDURAL PERIOD. TWO PATIENTS (4.8%) HAD TRANSIENT NEUROLOGICAL MOTOR DEFICITS WITHOUT CEMENT LEAKAGE, AND 1 PATIENT HAD A PULMONARY EMBOLISM WITH TRANSIENT MILD SYMPTOMS. THE COMPARISON OF PREPROCEDURAL VISUAL ANALOG SCALE AND OSWESTRY DISABILITY INDEX SCORES WITH POST-PROCEDURAL SCORES UP TO 6 MONTHS AFTER TREATMENT REVEALED SIGNIFICANT PAIN CONTROL AND GOOD FUNCTIONAL STATE. CONCLUSIONS: SPINAL METASTASIS IS A FREQUENT ENTITY IN THE GROWING POPULATION OF PATIENTS WITH CANCER. A MULTIDISCIPLINARY APPROACH USING SEVERAL NONSURGICAL AND MINIMALLY INVASIVE METHODS (E.G., RADIOFREQUENCY ABLATION, VERTEBROPLASTY, BALLOON KYPHOPLASTY) IS KEY TO SUCCESSFUL MANAGEMENT, AND COMBINING THESE PROCEDURES IS EFFECTIVE AGAINST SPINAL METASTATIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915132 UNKNOWN CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_BKP_CEMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other