BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTAFIX SHAPE MEMORY STAPLE

    MDR report key: 6265417 · Received January 19, 2017

    Report

    Report Number
    3010056267-2017-00002
    Event Type
    Injury
    Date Received
    January 19, 2017
    Date of Event
    November 4, 2014
    Report Date
    January 19, 2017
    Manufacturer
    OT MEDICAL, LLC
    Product Code
    JDR
    PMA / PMN Number
    K141550
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON STATED THAT THE EVENT OCCURRED DUE TO A NON-COMPLIANT PATIENT. IT WAS NOT THE RESULT OF THE DEVICE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE PATIENT WAS NON-COMPLIANT AND THE STAPLE WAS REMOVED AND REPLACED WITH A TWO HOLE PEANUT PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48635 INSTAFIX SHAPE MEMORY STAPLE STAPLE, FIXATION, BONE JDR OT MEDICAL, LLC 400-3703 206219514B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention