BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 3864347 · Received June 10, 2014

    Report

    Report Number
    1030489-2014-02731
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 12, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE AND BEGAN TO EXPERIENCE PAIN ABOUT 5 DAYS POST-OP ALONG WITH LOSS OF BOWEL CONTROL. THE PATIENT STATED THAT THE PAIN IS BEGINNING TO EXTEND TO THE UPPER BACK AND EXERCISE AND PAIN MEDICATION DO NOT HELP. ACCORDING TO THE REPORT, THE PHYSICIAN STATED THAT THERE IS "NOTHING ON THE X-RAYS THAT SHOW WHY THE PATIENT IS IN PAIN. SEVERAL X-RAYS HAVE BEEN DONE WHICH SHOW NO NEW FRACTURES." NO FURTHER INFORMATION WAS REPORTED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340596 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention CEMENT