BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MSB KYPHON® EXPRESS II

    MDR report key: 10330752 · Received July 28, 2020

    Report

    Report Number
    9612164-2020-02746
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Date of Event
    July 3, 2020
    Report Date
    August 12, 2022
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART # KEX152EB-INT ; LOT # 218471016 ANALYSIS SUMMARY: VISUAL AND FUNCTIONAL INSPECTION REVEALED THE BALLOON HAS BEEN DAMAGED. THE DAMAGE IS A SLICE IN THE MIDDLE PORTION OF THE BALLOON. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE BALLOON COMING IN CONTACT WITH BONE SPURS WHEN THE BALLOON IS INFLATED IN THE VERTEBRAL BODY. 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

    SIMILAR DEVICE KEX152EB-CDS WITH 510(K) NUMBER K123771. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM INITIAL REPORTER VIA MEDTRONIC FIELD REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PRE- OPERATIVE DIAGNOSIS OF OSTEOPOROSIS. IT WAS REPORTED THAT DURING THE BKP AND THE ASSOCIATED EXPANSION OF THE BALLOON IN THE VERTEBRA, THE BALLOON BURST WITH ABOUT 0.8 ML OF CONTRAST MEDIUM. IT WAS MENTIONED THAT THERE WAS NO DELAY IN OVERALL PROCEDURE DUE TO THIS EVENT. THERE WAS NO ADDITIONAL TREATMENT OR PROCEDURE PERFORMED AS A RESULT OF THIS EVENT. THERE WERE NO SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO COMPLICATIONS TO PATIENT/PHYSICIAN WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800267 MSB KYPHON® EXPRESS II ARTHROSCOPE HRX MEDTRONIC MEXICO KEX152EB-INT 218471016

    Patients

    Seq Age Sex Outcome Treatment
    1 Female