BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON INFLATABLE BONE TAMP

    MDR report key: 2515722 · Received April 3, 2012

    Report

    Report Number
    2953769-2012-00043
    Event Type
    Injury
    Date Received
    April 3, 2012
    Date of Event
    February 19, 2012
    Report Date
    March 12, 2012
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). SEX: 6 MALE PATIENTS. ARTICLE TITLED "TREATMENT OF TYPICAL AMYELIC SOMATIC FRACTURES WITH KYPHOPLASTY AND CALCIUM PHOSPHATE CEMENT: A CRITICAL ANALYSIS", BY G. GIOIA, D. MANDELLI, R. GOGUE.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "TREATMENT OF TYPICAL AMYELIC SOMATIC FRACTURES WITH KYPHOPLASTY AND CALCIUM PHOSPHATE CEMENT: A CRITICAL ANALYSIS", A STUDY WAS EVALUATED FOR TREATMENT OF THE FRACTURES PERFORMED WITH KYPHOPLASTY AND INJECTION OF CALCIUM PHOSPHATE. SURGERY WAS PERFORMED WITH GENERAL ANESTHESIA WITHIN 10 DAYS FROM THE TRAUMA. IN ALL CASES, A BILATERAL TRANSPEDICULAR APPROACH WAS USED. THE FOLLOWING WAS REPORTED IN THE RESULTS. THE POSTOPERATIVE X-RAY CONTROL SHOWED AN AVERAGE IMPROVEMENT OF 7.4º OF THE REGIONAL KYPHOSIS ANGLE; THIS VALUE WORSENED WITH REGARD TO THE POSTOPERATIVE CONTROL BY AN AVERAGE OF 6.6 º AT 45 DAYS. THE LOCAL KYPHOSIS ANGLE SHOWED AN AVERAGE POSTOPERATIVE IMPROVEMENT OF 9 º WITH A SUBSEQUENT AVERAGE WORSENING OF 9.2 º ON THE 45TH POSTOPERATIVE DAY CONTROL. CLINICALLY, PATIENTS REMAINED ASYMPTOMATIC IN FIVE CASES; IN ONE CASE, A LOCAL FRACTURE PAIN PERSISTED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHON INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Other