BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLATE, LEFT 73MM

    MDR report key: 5335379 · Received December 28, 2015

    Report

    Report Number
    MW5058794
    Event Type
    Malfunction
    Date Received
    December 28, 2015
    Date of Event
    September 30, 2015
    Report Date
    November 5, 2015
    Manufacturer
    TOBY ORTHOPAEDICS INC.
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    0

    Narratives

    Description of Event or Problem · 1

    DURING A PANTERA SHOULDER SURGERY, A 5.2MM POST SCREW PASSED THRU THE PLATE AND INTO THE BONE. THE POST POSITION WAS NOT PART OF FRACTURE FIXATION. THE SCREW WAS LEFT IN THE PT, NO HARM TO PT. PROLONGED SURGERY LESS THAN 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853077 PANTERA PROXIMAL HUMERUS FRACTURE FIXATION PLATE, LEFT 73MM BONE PLATE HRS TOBY ORTHOPAEDICS INC. TO-PANTERA 1500110202

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR