BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 2823211 · Received November 7, 2012

    Report

    Report Number
    2953769-2012-00159
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). LOCATION : HOSPITAL. THE DEVICES USED HAVE NOT BEEN 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 AT L1. DURING THE PROCEDURE, ONE OF THE INFLATABLE BONE TAMPS (IBT) WOULD NOT ADVANCE BEYOND THE TROCAR. ACCORDING TO THE REPORT, THE PHYSICIAN USED THE CURETTE AND THE DRILL TO VERIFY THAT THE PROBLEM WAS NOT DUE TO HARD BONE. AFTER SEVERAL ATTEMPTS, THE IBT STILL DID NOT ADVANCE SO A NEW IBT WAS USED TO COMPLETE THE CASE. THERE WAS A FIVE MINUTE DELAY IN THE OVERALL PROCEDURE TIME. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0006368045

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR TROCAR, DRILL, CURETTE