BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 3191470 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02556
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN. SURGERY DATE: MARCH 2013. DAY UNKNOWN. (B)(6). (B)(4). ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE 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 (BKP) DUE TO "A WORK INJURY, TRACTOR RELATED ACCIDENT, FRACTURED SPINE". FOLLOWING THE BKP AT LEVELS L1-L3, THE PATIENT BEGAN EXPERIENCING "TREMENDOUS AMOUNTS OF PAIN". THE PATIENT REPORTS THAT THE CONDITION HAS "NOT IMPROVED SINCE SURGERY" AND THERE IS STILL "SIGNIFICANT PAIN, BACK AND SACRAL," AND IT "FEELS TIGHT AND HURTS ALL THE TIME". IT WAS REPORTED THAT THE PHYSICIAN STATED THAT "NOTHING MORE COULD BE DONE". NO MRI OR CT SCANS HAVE BEEN DONE, ACCORDING TO THE REPORT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291276 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other