BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 14038817 · Received April 7, 2022

    Report

    Report Number
    1030489-2022-00329
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    September 8, 2021
    Report Date
    April 7, 2022
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NDN
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEAN AGE OF 72 YEARS (RANGE 82.74 - 60.3 YEARS). THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: 3 MALE AND 29 FEMALE PATIENTS. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. PRODUCT IDENTIFIER INFORMATION IS UNKNOWN OUTCOMES ATTRIBUTED TO ADVERSE EVENT: OTHER- PULMONARY CEMENT EMBOLISM. PRODUCT IDENTIFIER IS UNKNOWN, HENCE 510K# IS NOT AVAILABLE. THE DEVICE IS NOT ACCESSIBLE/RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    HUIZHI GUO1,2, HUASHENG HUANG1, YANG SHAO1 , QIULI QIN1 , DE LIANG2 , SHUNCONG ZHANG2 , YONGCHAO TANG2. ¿RISK FACTORS FOR PULMONARY CEMENT EMBOLISM (PCE) AFTER POLYMETHYLMETHACRYLATE AUGMENTATION: ANALYSIS OF 32 PCE CASES¿. EVENT DESCRIPTION: OBJECTIVE: PULMONARY CEMENT EMBOLISM (PCE) IS AN UNDERESTIMATED BUT POTENTIALLY FATAL COMPLICATION AFTER CEMENT AUGMENTATION. ALTHOUGH THE TREATMENT AND FOLLOW-UP OF PCE HAVE BEEN REPORTED IN THE LITERATURE, THE RISK FACTORS FOR PCE ARE SO FAR LESS INVESTIGATED. THIS STUDY AIMS TO IDENTIFY THE PREOPERATIVE AND INTRAOPERATIVE RISK FACTORS FOR THE DEVELOPMENT OF PCE. METHODS: A TOTAL OF 1,373 PATIENTS TREATED WITH THE POLYMETHYLMETHACRYLATE (PMMA) AUGMENTATION TECHNIQUE WERE RETROSPECTIVELY INCLUDED. PATIENTS WITH PCE WERE DIVIDED INTO VERTEBRAL AUGMENTATION GROUP AND SCREW AUGMENTATION GROUP. POSSIBLE RISK FACTORS WERE COLLECTED AS FOLLOWS: AGE, SEX, BONE MINERAL DENSITY, BODY MASS INDEX, DIAGNOSIS, COMORBIDITY, SURGICAL PROCEDURE, TYPE OF SCREW, AUGMENTED LEVEL, NUMBER OF AUGMENTED VERTEBRAE, FRACTURE SEVERITY, PRESENCE OF INTRAVERTEBRAL CLEFT, CEMENT VOLUME, MARKED LEAKAGE IN THE PARAVERTEBRAL VENOUS PLEXUS, AND PERIODS OF SURGERY. BINARY LOGISTIC REGRESSION ANALYSES WERE USED TO ANALYZE INDEPENDENT RISK FACTORS FOR PCE. RESULTS: PCE WAS IDENTIFIED IN 32 PATIENTS, WITH AN INCIDENCE RATE OF 2.33% (32 OF 1,373). FOR PATIENTS WHO HAD UNDERGONE VERTEBRAL AUGMENTATION, MARKED LEAKAGE IN THE PARAVERTEBRAL VENOUS PLEXUS (ODDS RATIO [OR], 1.2; 95% CONFIDENCE INTERVAL [CI], 0.1¿10.3; P = 0.000) AND PREVIOUS SURGERY (OR, 16.1; 95% CI, 4.2¿61.0; P = 0.007) WERE INDEPENDENT RISK FACTORS FOR PCE. REGARDING PATIENTS WHO HAD UNDERGONE SCREW AUGMENTATION, THE MARKED LEAKAGE IN THE PARAVERTEBRAL VENOUS PLEXUS (OR, 4.2; 95% CI, 0.5¿37.3; P = 0.004) WAS THE MAIN RISK FACTOR. CONCLUSION: MARKED LEAKAGE IN THE PARAVERTEBRAL VENOUS PLEXUS AND PREVIOUS SURGERY WERE SIGNIFICANT RISK FACTORS RELATED TO PCE. PA RAVERTEBRAL LEAKAGE AND OPERATOR EXPERIENCE SHOULD BE CONCERNED WHEN PERFORMING PMMA AUGMENTATION. PMMA-BASED CEMENT MATERIALS WERE USED FOR ALL PATIENTS. PART OF PATIENTS WHO RECEIVED VERTEBRAL AUGMENTATION WAS USED HIGH-VISCOSITY PMMA (CONFIDENCE SPINAL CEMENT SYSTEM, MEDTRONIC, MINNEAPOLIS, MN, USA) AT THE DISCRETION OF THE ATTENDING SURGERY. REPORTED EVENT: 1. 22 VERTEBRAL AUGMENTATION PATIENTS WITH PCE. TWO OF THESE PATIENTS HAD RECEIVED MEDTRONIC¿S CONFIDENCE CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824655 UNKNOWN CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SOFAMOR DANEK USA, INC MSB_UNK_BKP_CEMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other