BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 14974627 · Received July 11, 2022

    Report

    Report Number
    1030489-2022-00624
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    August 3, 2021
    Report Date
    July 11, 2022
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 77.8 YEARS (RANGE, 57-92 YEARS) A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED: 21 MEN, 64 WOMEN. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT P ROVIDED IN THE PUBLISHED LITERATURE. G2: COUNTRY- JAPAN NAOSUKE KAMEI, KIYOTAKA YAMADA, TOSHIO NAKAMAE, TAKESHI HIRAMATSU, TAKASHI HASHIMOTO, TOSHIAKI MARUYAMA, NOBUO ADACHI AND YOSHINORI FUJIMOTO, "RADIOGRAPHIC FACTORS FOR ADJACENT VERTEBRAL FRACTURES AND CEMENT LOOSENING FOLLOWING BALLOON KYPHOPLASTY IN PATIENTS WITH OSTEOPOROTIC VERTEBRAL FRACTURES", THE JAPANESE SOCIETY FOR SPINE SURGERY AND RELATED RESEARCH 2022; 6(2): 159-166, DOI.ORG/10.226 03/SSRR.2021-0112 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

    NAOSUKE KAMEI, KIYOTAKA YAMADA, TOSHIO NAKAMAE, TAKESHI HIRAMATSU, TAKASHI HASHIMOTO, TOSHIAKI MARUYAMA, NOBUO ADACHI AND YOSHINORI FUJIMOTO, "RADIOGRAPHIC FACTORS FOR ADJACENT VERTEBRAL FRACTURES AND CEMENT LOOSENING FOLLOWING BALLOON KYPHOPLASTY IN PATIENTS WITH OSTEOPOROTIC VERTEBRAL FRACTURES", THE JAPANESE SOCIETY FOR SPINE SURGERY AND RELATED RESEARCH 2022; 6(2): 159-166, DOI.ORG/10.226 03/SSRR.2021-0112 SUMMARY: BALLOON KYPHOPLASTY (BKP) IS A MINIMALLY INVASIVE SURGICAL APPROACH FOR THE TREATMENT OF OSTEOPOROTIC VERTEBRAL FRACTURES (OVF). SOME RISKS HAVE BEEN REPORTED AFTER TREATMENT WITH BKP; THEREFORE, IT IS NECESSARY TO DETERMINE WHEN BKPDOES NOT WORK. THUS, IN THIS STUDY, THE AIM WAS TO CLARIFY THE RADIOGRAPHIC PREDICTORS OF SECONDARY VERTEBRAL FRACTURES AND CEMENT LOOSENING AFTER BKP FOR OVF. THIS STUDY ENROLLED PATIENTS WITH SINGLE-LEVEL OVF AT THE THORACOLUMBAR JUNCTION (T11-L2) WHO UNDERWENT BKP FOR THE FIRST TIME BETWEEN JANUARY 2011 AND MARCH 2014. THE CLINICAL OUTCOMES WERE EVALUATED USING THE VISUAL ANALOG SCALE (VAS) AND A MODIFIED OSWESTRY DISABILITY INDEX (ODI) AT 1 WEEK AND 1, 3, 6, AND 12 MONTHS AFTER SURGERY. RADIOGRAPHIC ASSESSMENTS WERE PERFORMED PREOPERATIVELY AND WITHIN 1 YEAR AFTER BKP USING PLAIN RADIOGRAPHY AND COMPUTED TOMOGRAPHY. REPORTED EVENTS: 1. THE 85 PATIENTS WHO MET THE INCLUSION CRITERIA UNDERWENT BKP. THE AVERAGE AGE OF PARTICIPANTS (21 MEN, 64 WOMEN) WAS 77.8 YEARS (RANGE, 57-92 YEARS). 2. POLYMETHYL METHACRYLATE (PMMA)-CEMENT LEAKAGE WAS OBSERVED IN 18 PATIENTS (21.2%) BUT WAS ASYMPTOMATIC IN ALL CASES. PMMA LEAKED TO THE INTERVERTEBRAL DISC IN 11 CASES AND TO ANTERIOR OR LATERAL SIDE OF THE VERTEBRAL BODY IN 7 CASES BUT NOT TO THE SPINAL CANAL. 3. SECONDARY VERTEBRAL FRACTURES WERE DETECTED IN 20 PATIENTS (23.5%), INCLUDING ADJACENT LEVELS IN 15 PATIENTS (17.6%) AND NON-ADJACENT LEVELS IN 5 PATIENTS (5.9%). ROSTRAL BRIDGING OSTEOPHYTE FORMATION WAS FOUND TO BE SIGNIFICANTLY ASSOCIATED WITH THE OCCURRENCE OF ADJACENT VERTEBRAL FRACTURES (ODDS RATIO 12.746; P=0.010). 4. PMMA-CEMENT LOOSENING WAS OBSERVED IN THREE PATIENTS (3.5%). A HIGH PREVALENCE (100%) OF BRIDGING OSTEOPHYTES, VACUUM CLEFTS, AND SPINOUS PROCESS FRACTURES WAS OBSERVED IN PATIENTS WITH PMMA-CEMENT LOOSENING. PMMA-CEMENT LOOSENING WAS FOUND IN 3 OUT OF 10 PATIENTS WITH ALL THREE OF THESE FACTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014255 UNKNOWN CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_BKP_CEMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 932 MO Female