BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOSET

    MDR report key: 9013801 · Received September 12, 2019

    Report

    Report Number
    1043534-2019-00135
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    November 10, 2013
    Report Date
    August 16, 2019
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MQV
    PMA / PMN Number
    K963587
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: ARASTU ET AL. MINIMALLY INVASIVE REDUCTION AND FIXATION OF DISPLACED CALCANEAL FRACTURES: SURGICAL TECHNIQUE AND RADIOGRAPHIC ANALYSIS. INTERNATIONAL ORTHOPAEDICS (SICOT). 2014. 38:539-545. PATIENT INFO: 9 FEMALE, 22 MALE, 45.6 Y/O. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IN A 2014 CLINICAL STUDY, ARASTU ET AL TITLED " MINIMALLY INVASIVE REDUCTION AND FIXATION OF DISPLACED CALCANEAL FRACTURES: SURGICAL TECHNIQUE AND RADIOGRAPHIC ANALYSIS" THE AUTHORS REPORT SUPERFICIAL WOUND INFECTION IN 1 CASE (4.3%) USING A BONE GRAFT SUBSTITUTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796830 OSTEOSET FILLER, BONE VOID, CALCIUM COMPOUND MQV WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention