BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BKP CEMENT

    MDR report key: 11567370 · Received March 25, 2021

    Report

    Report Number
    2953769-2021-00011
    Event Type
    Malfunction
    Date Received
    March 25, 2021
    Date of Event
    January 11, 2021
    Report Date
    March 25, 2021
    Manufacturer
    MDT KYPHON SUNNYVALE MFG
    Product Code
    NDN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. AGED 59¿90 YEARS OLD (AVERAGE 75.12 ± 6.92 YEARS) 12 MALES AND 22 FEMALES IN PKP GROUP AND 9 MALES AND 21 FEMALES IN PVP GROUP. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    TITLE : PERCUTANEOUS VERTEBROPLASTY VERSUS KYPHOPLASTY FOR THE TREATMENT OF NEUROLOGICALLY INTACT OSTEOPOROTIC KÜMMELL¿S DISEASE. SUMMARY: ARTICLE REPORTS A PROSPECTIVE STUDY TO COMPARE AND INVESTIGATE THE SAFETY AND CLINICAL EFFICACY OF PERCUTANEOUS VERTEBROPLASTY (PVP; N=30 PATIENTS) AND KYPHOPLASTY (PKP; N=34 PATIENTS) TO TREAT NEUROLOGICALLY INTACT OSTEOPOROTIC KÜMMELL¿S DISEASE (KD). PKP WAS PERFORMED USING KYPHON BALLOONS UNDER BIPLANAR FLUOROSCOPIC GUIDANCE AND A TRANSPEDICULAR APPROACH. RESULTS: IT WAS REPORTED THAT 4 PATIENTS HAD BONE CEMENT LEAKAGE DURING THE OPERATION, MOST OF WHICH WERE LEAKAGE ALONG THE FRACTURE LINE. BUT NO CLINICAL SYMPTOMS OCCURRED IN THE TWO GROUPS. IN OTHER CASES, THE BONE CEMENT WAS WELL DISPERSED IN THE MIDDLE OR ANTERIOR POSITION OF THE VERTEBRA BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465453 BKP CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON SUNNYVALE MFG MSB_UNK_BKP_CEMENT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR