BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE FILLER DEVICE

    MDR report key: 385532 · Received March 29, 2002

    Report

    Report Number
    2953769-2002-00002
    Event Type
    Injury
    Date Received
    March 29, 2002
    Date of Event
    February 27, 2002
    Report Date
    March 29, 2002
    Manufacturer
    KYPHON INC.
    Product Code
    KIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT REQUIRED SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION DURING A FRACTURE REDUCTION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE FILLER DEVICE BONE FILLER DEVICE KIH KYPHON INC. F01A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention PMMA.