BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOLOC(TM)

    MDR report key: 7735283 · Received July 31, 2018

    Report

    Report Number
    1043534-2018-00073
    Event Type
    Injury
    Date Received
    July 31, 2018
    Report Date
    July 3, 2018
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: EITAN MELAMED ET AL. COMPLEX PROXIMAL ULNA FRACTURES: OUTCOMES OF SURGICAL TREATMENT. EUR J ORTHOP SURG TRAUMATOL. 2015; 25: 851-858. 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

    A TOTAL OF 38 PATIENTS WERE INCLUDED IN THE STUDY, OF THE 38 PATIENTS, 31 PATIENTS WERE TREATED WITH EITHER DEPUY-SYNTHES OR EVOLVE EPS PROXIMAL ULNA SPECIFIC PLATES (NUMBER OF PATIENTS TREATED WITH EITHER DEVICE WAS NOT SPECIFIED). OF THE 38 PATIENTS, ELEVEN PATIENTS HAD COMPLICATIONS (ARTICLE DID NOT SPECIFY IF THE PATIENTS WITH COMPLICATIONS WERE TREATED WITH EVOLVE EPS). THE COMPLICATIONS INCLUDED: HETEROTOPIC OSSIFICATION IN 10 PATIENTS, WITH 4 REQUIRING SURGICAL EXCISION BECAUSE OF RESTRICTED MOTION. ADDITIONAL SURGERY WAS PERFORMED IN 10 PATIENTS (26%) AND INCLUDED HARDWARE REMOVAL IN 9 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575988 ORTHOLOC(TM) PLATE, FIXATION, BONE HRS WRIGHT MEDICAL TECHNOLOGY, INC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention