BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BKP CEMENT

    MDR report key: 16434229 · Received February 24, 2023

    Report

    Report Number
    1030489-2023-00107
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    September 16, 2022
    Report Date
    February 24, 2023
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. PATIENT GENDER: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED ARTICLE. PRODUCT IDENTIFIER IS UNKNOWN. MARC PROD¿HOMME, MD; JÉRÔME TONETTI, MD, PHD; DUCCIO BOSCHERINI, MD, PHD; GUILLAUME CAVALIÉ, MD, MS; GAEL KERSCHBAUMER, MD; DIDIER GRASSET, MD; AND MEHDI BOUDISSA, MD, PHD. NAVIGATED CEMENTOPLASTY WITH O-ARM AND SURGIVISIO: AN AMBISPECTIVE COMPARISON WITH RADIATION EXPOSURE. INTERNATIONAL JOURNAL OF SPINE SURGERY, VOL. 16, NO. 5, 2022, PP. 944¿952. HTTPS:// DOI. ORG/ 10. 14444/ 8348 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

    SUMMARY: VERTEBRAL COMPRESSION FRACTURES (VCF) ARE FREQUENT INJURIES, MOSTLY RELATED TO HIGH ENERGY TRAUMAS ON YOUNG PEOPLE AND BONE FRAGILITY IN THE ELDERLY POPULATION. VCF ARE SUCCESSFULLY TREATED BY CEMENTOPLASTY, SUCH AS VERTEBROPLASTY OR KYPHOPLASTY. THESE PROCEDURES REQUIRE THE USE OF 2-DIMENSIONAL (2D) IMAGING FOR INTRAOPERATIVE CONTROL OF FRACTURE REDUCTION AND CEMENT FILLING. THE 3-DIMENSIONAL (3D) IMAGING WITH COMPUTERIZED NAVIGATION OFFERS CONFIDENCE AND ERGONOMY DURING SURGERY WITH MORE ACCURATE PROCEDURES. THE PURPOSE OF THIS STUDY WAS TO COMPARE THE IRRADIATION AND RADIOLOGICAL RESULTS OF PERCUTANEOUS CEMENTOPLASTY FOR VCF PERFORMED WI TH THE O-ARM SURGICAL SYSTEM ASSOCIATED TO THE NAVIGATION WITH THE ALL-IN- ONE 2D/3D IMAGING DEVICE WITH INTEGRATED NAVIGATION NAMED SURGIVISIO. HYPOTHESES WERE THAT CONSIDERING THE NEW SURGIVISIO DEVICE, O-ARM PRODUCES MORE IRRADIATION WITH LESS IMAGE QUALITY WITH RADIOLOGICAL RESULTS SIMILAR TO SURGIVISIO. IN PATIENTS WITH A LOSS OF HEIGHT OF THE OPERATED VERTEBRA OF MORE THAN 20% AND A LOCAL KYPHOSIS OF MORE THAN 10°, VERTEBRAL AUGMENTATION WAS PERFORMED USING A BALLOON KYPHON (MEDTRONIC, MINNEAPOLIS, MN, USA)12 FOR THE O-ARM GROUP. POLYMETHYL METHACRYLATE CEMENT WAS INJECTED ALONE FOR STANDARD VERTEBROPLASTY. FOR THE O-ARM GROUP, X¿PEDE CEMENT WAS USED (MEDTRONIC, MINNEAPOLIS, MN, USA), A TOTAL OF 123 PATIENTS WERE INCLUDED: 62 IN THE O-ARM GROUP AND 61 IN THE SURGIVISIO GROUP. SEX RATIO (MEN/WOMEN) WAS 24/38 FOR THE O-ARM GROUP AND 24/37 FOR THE SURGIVISIO GROUP. A TOTAL OF 166 VERTEBRAE WERE OPERATED: 81 IN THE O-ARM GROUP AND 85 IN THE SURGIVISIO GROUP. REPORTED EVENT: CEMENT LEAKAGE WAS LESS FREQUENT BUT NOT SIGNIFICANT IN THE O-ARM GROUP, WITH 16 (20%) VS 25 (29%) REPORTED IN THE SURGIVISIO GROUP, WITH A POSTERIOR LEAKAGE REQUIRING IMMEDIATE DECOMPRESSION IN THE O-ARM GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934425 BKP CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_BKP_CEMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female