BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHROSCOPE

    MDR report key: 3180238 · Received June 20, 2013

    Report

    Report Number
    1030489-2013-02427
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 22, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: DAISUKE TOGAWA, YUKIHIRO MATSUYAMA. "BALLOON KYPHOPLATY FOR OSTEOPOROTIC VERTEBRAL FRACTURES". MON BOOK ORTHOP 2013. GROUP A = MEAN AGE, 76 YEARS (49 TO 92 YEARS) AND GROUP B (CLINICAL TRIAL) = MEAN AGE, 74 YEARS. GROUP A = 37 FEMALES, 7 MALES. GROUP B = 64 FEMALES, 17 MALES. EVENT DATE IS UNKNOWN.(B)(6). (B)(4). LOCATION : HOSPITAL. ALTHOUGH IT IS UNKNOWN IF ANY MEDTRONIC 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 IN AN ARTICLE THAT A TOTAL OF 44 PATIENTS UNDERWENT BALLOON KYPHOPLASTY PROCEDURES (BKP) IN A 9 MONTH PERIOD TO TREAT OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES. THIS GROUP (GROUP A) WAS COMPARED TO 81 CASES OF CLINICAL TRIAL SUBJECTS THAT UNDERWENT BKP TO TREAT OVCF AS WELL (GROUP B). THE ARTICLE DESCRIBES INDICATIONS, INTERVENTION TIME, SURGICAL TECHNIQUE, TREATMENT EFFECTS, INFLUENCES ON QOL, AND COMPLICATIONS AND THEIR PREVENTION FOR BKP SURGERY FOR OVCF. IT WAS REPORTED THAT A POST-OPERATIVE INFECTION WAS OBSERVED IN ONE PATIENT FROM GROUP A. THE INFECTION WAS TREATED WITH ANTIBIOTICS. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281238 ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention BKP