BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 7446031 · Received April 20, 2018

    Report

    Report Number
    1030489-2018-00575
    Event Type
    Injury
    Date Received
    April 20, 2018
    Report Date
    April 20, 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 UPN (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 UNDERWENT BALLOON KYPHOPLASTY (BKP) AT TH12 DUE TO PRIMARY OSTEOPOROSIS,COMPRESSION FRACTURE. AFTER BKP OPERATION WAS PERFORMED AT TH12, FUSION WAS PERFORMED ON THE PATIENT WITH SCREW AT L1/2 AND TRANSVERSE HOOK AT TH12. AFTER OPERATION, THE CEMENT MIGRATED TO THE VENTRAL SIDE. ABOUT HALF OF THE CEMENT PROTRUDED. THIS WAS CONFIRMED ON (B)(6) 2018 IN IMAGING. REPORTEDLY, THERE WAS NEUROLOGICAL SYMPTOM DUE TO INSTABILITY. THERE WAS NO IMPACT WITH BLOOD VESSEL/MACROVASCULAR AT PRESENT. POSTERIOR FUSION WAS PLANNED TO BE PERFORMED LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289033 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN ELMDOWN LIMITED NA EL61316

    Patients

    Seq Age Sex Outcome Treatment
    1 Other