BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 8280673 · Received January 28, 2019

    Report

    Report Number
    3008572623-2019-00004
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    January 15, 2019
    Report Date
    January 28, 2019
    Manufacturer
    ELMDOWN LIMITED
    Product Code
    NDN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # C01A, 510K# K041584 AND UDI# (B)(4) WAS CLEARED IN THE UNITED STATES. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS: PAIN DUE TO VERTEBRAL FRACTURE AS A RESULT OF PRIMARY OSTEOPOROSIS AT THE SECOND LUMBAR VERTEBRA TYPE OF PROCEDURE BEING PERFORMED: PERCUTANEOUS VERTEBROPLASTY LEVELS IMPLANTED: SECOND LUMBAR IT WAS REPORTED THAT INTRA-OP, WHEN FILLING THE BONE CEMENT, THE CEMENT LEAKED INTO THE PATIENT'S SPINAL CANAL. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75763 KYPHX HV-R BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN ELMDOWN LIMITED NA EL70066

    Patients

    Seq Age Sex Outcome Treatment
    1