BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1834527 · Received September 10, 2010

    Report

    Report Number
    2953769-2010-00388
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Report Date
    August 17, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "RATIONALE FOR LIMITED SURGICAL INTERVENTION IN VERTEBRAL BODY FRACTURES OF THE OSTEOPOROTIC PT", BY TR BLATTERT, C SCHMIDT, JS JARVERS, C JOSTEN. METHOD - DEVICE NOT RETURNED; FOLLOW-UP WITH AUTHOR NOT POSSIBLE AS NO CONTACT INFO PROVIDED.

    Description of Event or Problem · 1

    IN AN ABSTRACT TITLED "RATIONALE FOR LIMITED SURGICAL INTERVENTION IN VERTEBRAL BODY FRACTURES OF THE OSTEOPOROTIC PT", THE FOLLOWING WAS NOTED: LEAKAGE OF CEMENT IN 41/208 PEDICLE SCREWS. DIRECTION OF LEAKAGE ANTERIOR/LATERAL FOR 40, EPIDURAL FOR 1 CASE. EXTRUSION OF CEMENT IN 3/52 CASES DURING THE KYPHOPLASTY PROCEDURE. NO ADDITIONAL INFO WAS REPORTED. NOTE: THE ABSTRACT DID NOT SPECIFICALLY IDENTIFY THE TYPE OF PMMA CEMENT THAT WAS USED DURING THE PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX HV-R BONE CEMENT HIGH VISCOSITY, RADIOPAQUE BONE CEMENT NDN MEDTRONIC SPINE LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR