BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 24855940 · Received April 13, 2026

    Report

    Report Number
    3003120897-2026-00680
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Report Date
    April 13, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NDN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2: MEDIAN PATIENT AGE AT SURGERY WAS 65 YEARS A.3B. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. D1, D.4. PRODUCT IDENTIFIERS ARE UNKNOWN. G4. PMA / 510(K) #- UNKNOWN AS PRODUCT IDENTIFIERS ARE UNKNOWN CITATION: SAFETY, EFFICACY, AND ADJACENT-LEVEL FRACTURE RISK FOLLOWING VERTEBRAL AUGMENTATION AND RADIOFREQUENCY ABLATION FOR THE TREATMENT OF SPINE METASTASES IN PATIENTS WITH CANCER. JEREMIAH STRINGAM, KOUSTAV PAL, ANDREW NIEKAMP, RAHIM JIWANI, IWAN PAOLUCCI, JOSHUA D. KUBAN, ZEYAD METWALLI, STEVEN HUANG, PEIMAN HABIBOLLAHI, STEPHEN CHEN, STEVEN YEVICH, MILAN PATEL, SUMIT K. SUBUDHI, MATTHEW CAMPBELL, AMOL GHIA, CLAUDIO TATSUI, RAHUL A. SHETH. RADIOLOGY: IMAGING CANCER 2025; 7(3):E240122. HTTPS://DOI.ORG/10.1148/RYCAN.240122 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING SAFETY, EFFICACY, AND ADJACENT-LEVEL FRACTURE RISK FOLLOWING VERTEBRAL AUGMENTATION COMBINED WITH RADIOFREQUENCY ABLATION FOR THE TREATMENT OF SPINAL METASTASES IN CANCER PATIENTS. THE FOLLOWING MEDTRONIC DEVICES WERE USED: VERTEBROPLASTY DEVICES AND BONE CEMENT (POLYMETHYL METHACRYLATE) MANUFACTURED BY MEDTRONIC. AMONG ALL PATIENTS ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: CEMENT LEAKAGE OCCURRED IN 127 OF 638 TREATED SPINAL LEVELS (20%). MOST LEAKAGE EVENTS INVOLVED THE INTERVERTEBRAL DISC SPACE AND HAD NO CLINICAL IMPACT. CEMENT LEAKAGE INTO THE NEUROFORAMEN OR EPIDURAL SPACE, WITH 4 CASES REQUIRING REPEAT SURGICAL INTERVENTION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922886 UNKNOWN CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC. MSB_UNK_BKP_CEMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown