BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II INFLATABLE BONE TAMP

    MDR report key: 10499542 · Received September 7, 2020

    Report

    Report Number
    1030489-2020-01210
    Event Type
    Malfunction
    Date Received
    September 7, 2020
    Date of Event
    August 12, 2020
    Report Date
    April 6, 2021
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: DEVICE EVALUATED SUMMARY - VISUAL AND FUNCTIONAL INSPECTION REVEALED THE BALLOON HAS BEEN PUNCTURED. THE DAMAGE IS A PINHOLE IN THE MIDDLE OF THE BALLOON. THIS DAMAGE IS CONSISTENT WITH THE BALLOON COMING IN CONTACT WITH BONE SPURS WHEN THE BALLOON IS INFLATED IN THE VERTEBRAL BODY. THIS DEVICE IS NOT MARKETED IN THE UNITED STATES, LIKE DEVICE CATALOG#- KX153, 510(K)#- K101864, (B)(4) IS APPROVED IN THE UNITED STATES. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.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.

    Additional Manufacturer Narrative · 1

    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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH VERTEBRAL COMPRESSION FRACTURE (VCF) INVOLVED IN SPINAL THERAPY. IT WAS REPORTED THAT DURING PROCEDURE, BALLOON COULD NOT BE INFLATED AS IT WAS BROKEN OR RUPTURED. BALLOON PROBABLY BROKEN OR BALLOON RUPTURED BEFORE INFLATING. THE SECOND BALLOON COULD BE INFLATED NORMALLY. SO, THE PROCEDURE WAS COMPLETED. THERE IS NO ADDITIONAL SURGERY PERFORMED AS A RESULT OF THE EVENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS THE RESULT OF EVENT. PATIENT IS ALIVE AND NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963280 KYPHON XPANDER II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO KPX203RB-C 219921661

    Patients

    Seq Age Sex Outcome Treatment
    1