BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1409119 · Received June 30, 2009

    Report

    Report Number
    2953769-2009-00065
    Event Type
    Injury
    Date Received
    June 30, 2009
    Date of Event
    January 26, 2009
    Report Date
    June 1, 2009
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    PMA / PMN Number
    K033801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: "PREDICTORS OF SUCCESSFUL PALLIATION OF COMPRESSION FRACTURES WITH VERTEBRAL AUGMENTATION: SINGLE-CENTER EXPERIENCE OF 525 CASES" BU RUCHIRA M. JHA, MD, ALBERT J. YOO, MD, ARIEL E. HIRSCH, MD, MARION GROWNEY, MSN, ACNP, AND JOSHUA A. HIRSCH, MD. DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE, FOLLOW UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN A LITERATURE REVIEW, THE SOURCE LITERATURE REPORTED THREE EVENTS RELATED TO KYPHOPLASTY: CASE #1: THE PATIENT REQUIRED REPEAT TREATMENT OF THE SAME VERTEBRAL LEVEL.

    Additional Manufacturer Narrative · 2

    REPORT SOURCE: "PREDICTORS OF SUCCESSFUL PALLIATION OF COMPRESSION FRACTURES WITH VERTEBRAL AUGMENTATION: SINGLE-CENTER EXPERIENCE OF 525 CASES" BU RUCHIRA M. JHA, MD, ALBERT J. YOO, MD, ARIEL E. HIRSCH, MD, MARION GROWNEY, MSN, ACNP, AND JOSHUA A. HIRSCH, MD. DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE, FOLLOW UP WITH AUTHOR.

    Description of Event or Problem · 2

    IN A LITERATURE REVIEW, THE SOURCE LITERATURE REPORTED THREE EVENTS RELATED TO KYPHOPLASTY: CASE #2: A CEMENT PULMONARY EMBOLUS OCCURRED IN A PATIENT WITH OSTEOPOROSIS. NO COMPLICATIONS WERE NOTED AT THE TIME OF THE PROCEDURE, BUT IT WAS DOCUMENTED BY THE PATIENT'S PRIMARY PHYSICIAN 2 MONTHS AFTER THE PROCEDURE. THE METHOD OF DISCOVERY WAS NOT COMMENTED ON. THE PATIENT WAS PRESCRIBED WARFARIN AND FOLLOW-UP WAS UNEVENTFUL. ADDITIONAL INFORMATION OBTAINED FROM THE AUTHOR REPORTED THAT DURING THE PROCEDURE, MULTIPLE LEVELS WERE TREATED IN A SINGLE SESSION (WITH KYPHOPLASTY AND VERTEBROPLASTY) AND THAT THE PATIENT WAS ASYMPTOMATIC.

    Additional Manufacturer Narrative · 3

    REPORT SOURCE: "PREDICTORS OF SUCCESSFUL PALLIATION OF COMPRESSION FRACTURES WITH VERTEBRAL AUGMENTATION: SINGLE-CENTER EXPERIENCE OF 525 CASES" BU RUCHIRA M. JHA, MD, ALBERT J. YOO, MD, ARIEL E. HIRSCH, MD, MARION GROWNEY, MSN, ACNP, AND JOSHUA A. HIRSCH, MD. DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE, FOLLOW UP WITH AUTHOR.

    Description of Event or Problem · 3

    IN A LITERATURE REVIEW, THE SOURCE LITERATURE REPORTED THREE EVENTS RELATED TO KYPHOPLASTY: CASE #3: A RUPTURE OF A BALLOON THROUGH THE LATERAL WALL OCCURRED IN A PATIENT WITH OSTEOPOROSIS, IT WAS ADDRESSED IMMEDIATELY BY THE PLACEMENT OF POLYMETHYLMETHACRYLATE IN ESSENCE RECREATING THE LATERAL WALL. NO ADDITIONAL TREATMENT WAS REQUIRED, AND THIS WAS BELIEVED TO BE CLINICALLY ASYMPTOMATIC. THE SOURCE LITERATURE DID NOT INCLUDE ANY DEVICE SPECIFICS.

    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 75 YR Other| R
    2 82 YR
    3