BEUDAMED
    FDA Adverse Event Summary report: N

    OSSEOFLEX SN+

    MDR report key: 6146522 · Received December 5, 2016

    Report

    Report Number
    3007111981-2016-00002
    Date Received
    December 5, 2016
    Date of Event
    November 11, 2016
    Report Date
    December 5, 2016
    Manufacturer
    OSSEON LLC
    Product Code
    OAR
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    DURING THE VERTEBRAL AUGMENTATION PROCEDURE, THE DEVICE WAS LEFT IN THE PATIENT FOR APPROXIMATELY 15 MINUTES AFTER THE CEMENT WAS INJECTED. THE DELAY CAUSED THE CEMENT TO HARDEN AND A PORTION OF THE DISTAL NEEDLE BROKE OFF (LESS THAN 40MM) AND REMAINED IN THE PATIENT AS THE NEEDLE COULD NOT BE DISLODGED. NO IMAGE WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797430 OSSEOFLEX SN+ STEERABLE VERTEBRAL NEEDLE OAR OSSEON LLC OF-0021 081015-01

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization