BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER¿ II INFLATABLE BONE TAMP

    MDR report key: 11804499 · Received May 11, 2021

    Report

    Report Number
    9612164-2021-01845
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 16, 2021
    Report Date
    August 8, 2022
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PART # KPX153RB-C, LOT# 221468008 VISUAL AND OPTICAL INSPECTION CONFIRMED THE IBT IS CRACKED AT THE ATTACHMENT VALVE. FUNCTIONAL INSPECTION WITH A SAMPLE SYRINGE CONFIRMED THE IBT IS LEAKING AT THE CRACK. IT APPEARS THE IBT WAS CRACKED DUE TO BEND STRESS OVERLOAD. 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

    THIS PRODUCT IS NOT MARKETED IN US. HOWEVER, THE SIMILAR DEVICE WITH PRODUCT ID: KPX153RB WITH 510(K)# K101864 IS MARKETED IN US. 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 FOR AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT BALLOON LEAKAGE WAS NOTICED IMMEDIATELY WHEN THE CONTRAST AGENT WAS INJECTED IN THE VERTEBRAE AND STOPPED. THERE WAS RUPTURE OCCURRED DURING INFLATION. THE BALLOON WAS EXCHANGED FOR A REPLACEMENT. NO DAMAGE TO THE PATIENT. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. (B)(6) 2021E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT LOT NUMBER IS 221468006. THERE WAS NO EXTRAVASION OBSERVED INSIDE THE PATIENT. THE PRE-OP DIAGNOSIS INVOLVED IN THE EVENT WAS VERTEBRAE FRACTURE, PROCEDURE INVOLVED IN THE EVENT WAS BKP AND LEVELS IMPLANTED WAS 1. THE PRODUCT DID CAME IN CONTACT WITH THE PATIENT. AFTER THEY NOTICED THAT THERE WAS A LEAKAGE, THE EXCHANGED THE BALLOON AND FINISHED THE SURGERY SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704085 KYPHON XPANDER¿ II INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC MEXICO KPX153RB-C 221468008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown