BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KYPHOPLASTY

    MDR report key: 2545590 · Received April 23, 2012

    Report

    Report Number
    2953769-2012-00069
    Event Type
    Injury
    Date Received
    April 23, 2012
    Report Date
    March 27, 2012
    Manufacturer
    MDT KYPHON SUNNYVALE MFG
    Product Code
    HRX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE BY Z. KLEZL, ET.AL, ENTITLED IMPACT OF KYPHOPLASTY TREATMENT FOR VERTEBRAL COMPRESSION FRACTURES ON PAIN AND FUNCTION IN 105 PATIENTS, IT WAS REPORTED THAT 105 PATIENTS UNDERWENT KYPHOPLASTY BETWEEN (B)(6) 2006 AND (B)(6) 2010 AND ALL HAD 1 YEAR FOLLOW UPS. A TOTAL OF 170 LEVELS WERE AUGMENTED. PAIN RELIEF WAS ASSESSED USING VISUAL ANALOGUE SCORE (VAS) AND FUNCTIONAL OUTCOME USING OSWESTRY DISABILITY INDEX (ODI). KYPHOPLASTY WAS PERFORMED USING PRONE POSITION ON A MONTREAL MATTRESS. KYPHON INSTRUMENTATION AND BI-PEDICULAR (T8-S1) AND BI-EXTRAPEDICULAR OR UNI-EXTRA-PEDICULAR APPROACH WAS USED (T5-T8). MOST CASES INVOLVED A SINGLE LEVEL OR 2 LEVELS AUGMENTED. NO MORE THAN 4 LEVELS WERE AUGMENTED DURING ANY ONE PROCEDURE. THE AVERAGE SCREENING TIME WAS 2 MINUTES AND 20 SECONDS AND THE AVERAGE VOLUME OF CEMENT USED PER LEVEL WAS 5.5CM. THE AVERAGE PRE-OPERATIVE VAS WAS 8.2. THE AVERAGE ONE YEAR POST-OPERATIVE VAS WAS 3.6. THE AVERAGE PRE-OPERATIVE ODI WAS 58. THE AVERAGE ONE YEAR POST-OPERATIVE ODI WAS 38. IT WAS REPORTED THAT A PATIENT EXPERIENCED BLEEDING AND HEMATOMA. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN KYPHOPLASTY ARTHROSCOPE HRX MDT KYPHON SUNNYVALE MFG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention