BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II INFLATABLE BONE TAMP

    MDR report key: 12047503 · Received June 23, 2021

    Report

    Report Number
    9612164-2021-02435
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    May 31, 2021
    Report Date
    September 22, 2021
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, H3, H6 H3. DEVICE EVALUATION SUMMARY: PRODUCT ANALYSIS #704423518:PART # KPX153RB-C LOT # 221016804 VISUAL AND FUNCTIONAL INSPECTION CONFIRMED THE SYRINGE HAS SOME DRIED MEDIA IN THE TUBE OF THE SYRINGE. PRESENCE OF DRIED CONTRAST MEDIA IN THE TUBE OF THE SYRINGE INDICATES THAT THE SYRINGE HAS BEEN USED AT LEAST ONE TIME. FUNCTIONAL INSPECTION CONFIRMED THE DISPLAY WOULD NOT POWER ON. UNABLE TO TEST SYRINGE FOR LEAK DUE TO THE DRIED MEDIA IN THE LINE. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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

    COUNTRY: (B)(6). PMA/510(K)#: THIS PRODUCT IS NOT MARKETED IN US. HOWEVER, THE SIMILAR DEVICE WITH PRODUCT ID: KPX153RB WITH 510(K)# K101864 IS M ARKETED IN US. H3: 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 A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN INDICATION OF L1 VERTEBRAL COMPRESSION IN NEED OF SPINAL THERAPY. IT WAS REPORTED THAT AS SOON AS THE DOCTOR STARTED TWISTING THE HAND PIECE FOR THE BALLOON TO EXPAND, IT IMMEDIATELY STARTED LEAKING CONTRAST OUT OF THE BACK OF THE HANDLE PIECE. THE SECOND HANDLE ALSO STARTED LEAKING IMMEDIATELY, AS SOON AS IT WAS STARTED TO ASPIRATE THE CONTRAST. THE FAULT WAS FOUND WITH THE NEWLY OPENED KIT. THE PRODUCT COME IN CONTACT WITH THE PATIENT. THE LEAKAGE DIDN'T HAPPEN INSIDE THE PATIENT (AWAY FROM THE PATIENT). THERE WAS A DELAY OF LESS THAN 60 MINS REPORTED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947175 KYPHON XPANDER II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO KPX153RB-C 221016804

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR