BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 8303638 · Received February 4, 2019

    Report

    Report Number
    2953769-2019-00003
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Date of Event
    December 28, 2018
    Report Date
    February 4, 2019
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG# C01A, 510K# K160983 AND UDI# (B)(4). IS APPROVED FOR SALE IN US. THE PRODUCT IS NOT RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF 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 PERCUTANEOUS VERTEBROPLASTY PROCEDURE. DURING SURGERY, THE CEMENT SOLIDIFIED BEFORE INJECTING. THE CEMENT WAS STORED AT PROPER TEMPERATURE BEFORE AND DURING THE PROCEDURE (BELOW 25 ° C DURING STORAGE; 23 +/- 1 ° C FOR 24 HOURS PRIOR TO USE).THE PRODUCT CAME IN CONTACT WITH THE PATIENT. NO HEALTH DAMAGE WAS REPORTED IN PATIENT AS A RESULT OF ALLEGED EVENT. THERE WAS A DELAY OF LESS THAN 60 MINS IN PROCEDURE TIME AS A RESULT OF ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94649 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MDT KYPHON NEUCHATEL MFG NA EL70066

    Patients

    Seq Age Sex Outcome Treatment
    1