BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 15630829 · Received October 19, 2022

    Report

    Report Number
    1030489-2022-00967
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    February 12, 2022
    Report Date
    October 19, 2022
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE OR DATE OF BIRTH: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED: 57.1 YEARS (RANGE: 33-86 YEARS) ETHNICITY: THIS VALUE IS THE AVERAGE ETHNICITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED: 21 WERE CAUCASIAN AND 2 WERE AFRICAN AMERICAN. DATE OF EVENT: 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. PRODUCT IDENTIFIERS ARE UNKNOWN. DATE REC¿D BY MFR: 510(K)# IS UNKNOWN. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. ANDREW RAGHEB, AIMEN VANOOD, DANIEL K. FAHIMA "THE ADDITION OF RADIOFREQUENCY TUMOR ABLATION TO KYPHOPLASTY MAY REDUCE THE RATE OF LOCAL RECURRENCE IN SPINAL METASTASES SECONDARY TO BREAST CANCER" WORLD NEUROSURG. (2022) 161:E500-E507. DOI: 10.1016/J.WNEU.2022.02.052. 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

    ANDREW RAGHEB, AIMEN VANOOD, DANIEL K. FAHIM "THE ADDITION OF RADIOFREQUENCY TUMOR ABLATION TO KYPHOPLASTY MAY REDUCE THE RATE OF LO CAL RECURRENCE IN SPINAL METASTASES SECONDARY TO BREAST CANCER" WORLD NEUROSURG. (2022) 161:E500-E507. DOI: 10.1016/J. WNEU.2022.02.052 SUMMARY: RETROSPECTIVE MEDICAL CHART ANALYSIS OF BREAST CANCER PATIENTS (N = 23) WITH METASTATIC SPINAL FRACTURES (N = 50 VERTEBRAL LEVELS) WHO UNDERWENT RFA AND KYPHOPLASTY WAS UNDERTAKEN. KEY VARIABLES OF INTEREST INCLUDED: FRACTURE LOCATION, PAIN LEVELS, AND LOCAL RECURRENCE. LOCAL RECURRENCE DATA WERE COMPARED TO PUBLISHED RATES OF RECURRENCE IN BREAST CANCER RELATED METASTATIC SPINAL FRACTURES TREATED WITH VERTEBROPLASTY OR KYPHOPLASTY ALONE. DATA WERE ANALYZED USING C2 AND T TEST STATISTICAL ANALYSES. REPORTED EVENT: 1. THE 23 PATIENTS HAD AN AVERAGE AGE OF 57.1 YEARS AT THE TIME OF SURGERY (RANGE: 33-86 YEARS). ALL PATIENTS WERE FEMALE; 21 WERE C AUCASIAN AND 2 WERE AFRICAN AMERICAN. 2. OF THE 23 PATIENTS, 18 OF THEM PRESENTED WITH SPINAL METASTASIS SECONDARY TO PRIMARY INVASIVE DUCTAL CARCINOMA. TWO PATIENTS PRESENTED WITH METASTASIS SECONDARY TO LOBULAR CARCINOMA AND 1 PATIENT PRESENTED WITH METASTASIS SECONDARY TO INFLAMMATORY CARCINOMA. THE BREAST CANCER SUBTYPE WAS UNKNOWN IN 2 PATIENTS. OF THE RESULTING 50 VERTEBRAL COMPRESSION FRACTURES THAT WERE OPERATED UPON, 30 WERE LOCATED IN THE THORACIC SPINE (60%) AND 20 WERE LOCATED IN THE LUMBAR SPINE (40%). 3. NO SIGNIFICANT CHANGES IN NEUROLOGIC STATUS WERE OBSERVED POSTOPERATIVELY. ONE PATIENT EXPERIENCED MILD NUMBNESS AND TINGLING IN ALL 4 EXTREMITIES THAT RESOLVED SPONTANEOUSLY WITHIN 1 WEEK OF SURGERY. THE ETIOLOGY OF THESE SYMPTOMS WAS UNCLEAR. 4. LIKEWISE, NO CASES OF SYMPTOMATIC CEMENT EXTRAVASATION WERE NOTED. THREE PATIENTS HAD MINOR CEMENT EXTRAVASATION THAT WAS NOTED ON POSTOPERATIVE IMAGING, BUT THERE WERE NO NEUROLOGIC CONSEQUENCES OR RELATED SYMPTOMS. 5. OF THESE 50 VERTEBRAL BODIES, 1 CASE OF LOCAL TUMOR RECURRENCE WAS OBSERVED AT 1 OF THE TREATED VERTEBRAL BODIES (2%). THIS CASE OF LOCAL RECURRENCE OCCURRED 4 YEARS AFTER THE INITIAL SURGERY. RESULTS: THE MEAN PREOPERATIVE PAIN LEVEL FOR THIS COHORT WAS 6.9 ON A 10-POINT VISUAL ANALOGUE SCALE. SIGNIFICANT REDUCTIONS IN PAIN LEVELS WERE OBSERVED POSTOPERATIVELY, AT DISCHARGE (3.5; P <(><<)> 0.05), AT 1-MONTH FOLLOW UP (2.8; P <(><<)> 0.05), AT 3-MONTH FOLLOW-UP (1.1; P <(><<)> 0.05), AND AT 6-MONTH FOLLOW-UP (0.7 P <(><<)> 0.05). COMPARED WITH PUBLISHED DATA OF BREAST CANCER PATIENTS WITH METASTATIC SPINAL FRACTURES TREATED WITH VERTEBROPLASTY OR KYPHOPLASTY ALONE, THE ADDITION OF RFA RESULTED IN REDUCED LOCAL TUMOR RECURRENCE (2% VS. 14%; P <(><<)> 0.05). AVERAGE LENGTH OF FOLLOW UP WAS 39 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2047368 UNKNOWN CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_BKP_CEMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female