BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON INFLATABLE BONE TAMP

    MDR report key: 11567333 · Received March 25, 2021

    Report

    Report Number
    9612164-2021-01148
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    January 11, 2021
    Report Date
    March 25, 2021
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HRX
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: 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. AGE OR DATE OF BIRTH: AGED 59¿90 YEARS OLD (AVERAGE 75.12 ± 6.92 YEARS). SEX: 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. DURING THE POSTOPERATIVE REHABILITATION, TRANSIENT FEVER APPEARED IN 2 PATIENTS IN THE PKP GROUP AND 2 PATIENTS IN THE PVP GROUP. BODY TEMPERATURE RETURNED TO BE NORMAL AFTER SUPPORTIVE TREATMENT. DURING THE POSTOPERATIVE FOLLOW-UP PERIOD, 3 PATIENTS IN THE PVP GROUP AND 1 PATIENT IN THE PKP GROUP HAD RE-FRACTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464488 KYPHON INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO KY_UNK_PLASTY

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other