BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 7198975 · Received January 17, 2018

    Report

    Report Number
    3008572623-2018-00001
    Event Type
    Injury
    Date Received
    January 17, 2018
    Date of Event
    December 22, 2017
    Report Date
    January 17, 2018
    Manufacturer
    ELMDOWN LIMITED
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# C01A, 510K# K041584 AND (B)(4) IS APPROVED FOR THE MARKET. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE 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 PRESENTED WITH PRIMARY OSTEOPOROSIS AND COMPRESSION FRACTURE AT L2. POST-OP, A SAGITTAL IMAGE OF THE SITE CONFIRMED SLIGHT CEMENT DEVIATION INTO SPINAL CANAL. PATIENT SUFFERED WITH LOWER EXTREMITY PAIN DUE TO THE EVENT. AS A RESULT, FORAMINOTOMY WAS PLANNED TO BE ADDED. THE OPERATION OF CLOSING THE WOUND WAS PERFORMED TEMPORARILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44813 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN ELMDOWN LIMITED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other