BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 3133519 · Received May 29, 2013

    Report

    Report Number
    2953769-2013-00083
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    February 16, 2012
    Report Date
    January 26, 2016
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE (BKP) TO TREAT AN OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE AT L1. IT WAS REPORTED THAT "CEMENT LEAKAGE WAS OBSERVED" INTRA-OPERATIVELY. ACCORDING TO THE REPORT, THE PATIENT IS ASYMPTOMATIC AND THE CEMENT EXTRAVASATED AT THE DISC LEVEL. THE CEMENT VISCOSITY WAS REPORTEDLY "DOUGHY AND HOMOGENOUS" PRIOR TO INJECTION. NO OTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    THE CAUSAL RELATIONSHIP BETWEEN THE EVENT CEMENT LEAKAGE AND THE BKP PRODUCTS HAS BEEN CHANGED TO ¿NOT RULED OUT¿ FROM ¿NOT RELATED (DUE TO THE TECHNICAL FACTOR)¿. THE OUTCOME REMAINED UNCHANGED AS NO HEALTH DAMAGE WITH AN OUTCOME DATE OF (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236742 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SPINE LLC. NA EL35410

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR