BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER¿ II INFLATABLE BONE TAMP

    MDR report key: 5509977 · Received March 18, 2016

    Report

    Report Number
    2953769-2016-00024
    Event Type
    Malfunction
    Date Received
    March 18, 2016
    Date of Event
    February 17, 2016
    Report Date
    April 12, 2016
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K101864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (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.

    Additional Manufacturer Narrative · 1

    ANALYSIS: DURING VISUAL ANALYSIS, NO PROBLEM HAS BEEN DETECTED ON THE IBT. DURING FUNCTIONAL ANALYSIS, THE IBT WAS UNABLE TO MAINTAIN PRESSURE, PROBABLY DUE TO A HOLE. AFTER FURTHER ANALYSIS, THE HOLE WAS CONFIRMED AND LOCATED BETWEEN THE TWO PEAK OF THE BALLOON THIS IS A VERY SMALL HOLE WHERE WATER IS SPRAYING WHEN UNDER PRESSURE. CONCLUSION: BASED ON THE INFORMATION PROVIDED, VISUAL AND FUNCTIONAL ANALYSIS, THE MOST PROBABLE ROOT CAUSE OF THE RUPTURE OF THE BALLOON IS ATTRIBUTED TO THE CONTACT WITH BONE SPLINTERS DURING SURGERY. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: BWK 12 FRACTURE LEVELS IMPLANTED: BWK 12 IT WAS REPORTED THAT ON (B)(6) 2016, INTRA-OP, BOTH BALLOONS RUPTURED IN THE VERTEBRAE BODY, DURING THE BKP EVENT. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166465 KYPHON XPANDER¿ II INFLATABLE BONE TAMP ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0007760074

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR