BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX INFLATABLE BONE TAMP

    MDR report key: 1741410 · Received June 28, 2010

    Report

    Report Number
    2953769-2010-00218
    Event Type
    Injury
    Date Received
    June 28, 2010
    Report Date
    June 8, 2010
    Manufacturer
    KYPHON, INC.
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED; FOLLOWED UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE ON (B)(6) 2010. POSTOPERATIVELY, THE PT REPORTED HAVING "EXTREME PAIN IN HIS BUTTOCKS, HIPS AND REAR-END" AND THAT THE "PAIN IS WORSE THAN PREOPERATIVELY." IT WAS NOTED THAT THE PHYSICIAN HAD SUGGESTED THE PT TAKE PAIN PILLS. NO ADDITIONAL INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX INFLATABLE BONE TAMP INFLATABLE BONE TAMP HRX KYPHON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other