BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHOPAK TRAY

    MDR report key: 11869160 · Received May 24, 2021

    Report

    Report Number
    2953769-2021-00021
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    April 15, 2021
    Report Date
    May 24, 2021
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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. 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) VIA THE MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A SPINAL PROCEDURE IN PATIENT DIAGNOSED WITH L2 FRACTURE. IT WAS REPORTED THAT THE CEMENT LEAKED AT THE CONNECTION POINT OF THE BONE FILLERS AND MULTITAP. A PART OF CEMENT WAS LOST. FOR THE PROCEDURE IT WAS NOT A PROBLEM BECAUSE THERE WAS ENOUGH CEMENT IN THE BONE FILLERS. THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY /COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770100 KYPHOPAK TRAY HRX MDT KYPHON NEUCHATEL MFG KPX153RB-C 219586193

    Patients

    Seq Age Sex Outcome Treatment
    1