BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 3972140 · Received July 31, 2014

    Report

    Report Number
    2953769-2014-00100
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOCATION : UNKNOWN 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 BALLOON KYPHOPLASTY (BKP) AT T12 TO TREAT A VERTEBRAL COMPRESSION FRACTURE. APPROXIMATELY TWO MONTHS POST-OP, IT WAS NOTED THAT THE PATIENT HAD A HIGH LEVEL OF CRP (C-REACTIVE PROTEIN) AND MRI IMAGING TESTS SHOWED POTENTIAL INFECTION. ACCORDING TO THE REPORT "IT WAS DOUBTED THAT THE INFECTION WAS CAUSED FROM ANTIBIOTIC MEDICATION AS IT RELIEVED THE PATIENT'S PAIN BUT IS NOW STABLE". NO OTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448231 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention