BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON XPANDER II INFLATABLE BONE TAMP

    MDR report key: 10248049 · Received July 8, 2020

    Report

    Report Number
    9612164-2020-02486
    Event Type
    Injury
    Date Received
    July 8, 2020
    Date of Event
    March 17, 2020
    Report Date
    October 13, 2020
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS- PRODUCT ANALYSIS AND VISUAL EXAMINATION DID NOT REVEAL ANY DAMAGE TO THE SHAFT OR THE BALLOON OF THE IBT. FUNCTIONAL EVALUATION WITH A SAMPLE SYRINGE CONFIRMED THE IBT WOULD INFLATE/DEFLATE WITHOUT ANY SIGNS OF LEAKING. THE INSTRUMENT APPEARS TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION. NO FAULT FOUND. 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

    INTERVENTION REQUIRED: BKP PROCEDURE WAS CHANGED TO VERTEBROPLASTY. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # KX153, 510K # K101864 WAS CLEARED IN THE UNITED STATES. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY (BKP) AT T9 DUE TO COMPRESSION FRACTURE. INTRA-OP, WHEN THE BALLOON WAS INSERTED AND INFLATION WAS TRIED, THE BALLOON COULD NOT BE INFLATED. THIS WAS THE BALLOON FROM THE SECOND KIT THAT WAS OPENED TO COMPLETE THE PROCEDURE. BEFORE THIS BALLOON, TWO OTHER BALLOONS FROM ANOTHER KIT HAD THE SAME ISSUE. IT WAS FOUND THAT THE BALLOONS LEAKED CONTRAST, WHICH PREVENTED BALLOON INFLATION; AND HENCE, BKP COULD NOT BE PERFORMED. EVENTUALLY, THE SURGEON PERFORMED VERTEBROPLASTY. NO FRAGMENT OF THE BALLOONS REMAINED INSIDE THE PATIENT. THERE WAS DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS RESULT OF THIS EVENT; BUT NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711881 KYPHON XPANDER II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO NA 218414674

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention