BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOFLEX SN, STEERABLE NEEDLE 10GA WITH ACCESS KIT

    MDR report key: 5957205 · Received September 16, 2016

    Report

    Report Number
    3007111981-2016-00001
    Event Type
    Injury
    Date Received
    September 16, 2016
    Date of Event
    June 6, 2016
    Report Date
    July 5, 2016
    Manufacturer
    OSSEON LLC
    Product Code
    GAA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING TRAVELER AND INSPECTION RECORDS FOR DEVICE SHOW THAT IT WAS MANUFACTURED WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    DURING A KYPHOPLASTY PROCEDURE AS THE PHYSICIAN BEGAN TO REMOVE THE DE-ARTICULATED VERTEBRAL AUGMENTATION NEEDLE, THE TIP BROKE OFF AND REMAINED IN THE PATIENT'S PEDICLE. AFTER MAKING ATTEMPTS OT REMOVE THE TIP, PHYSICIAN REFERRED PATIENT TO SPINE SPECIALIST AND INQUIRED HOW TO REMOVE THE TIP WITH OSSEON'S R&D DEPARTMENT. SUBSEQUENTLY, THE SPINE SPECIALIST REMOVED THE NEEDLE TIP WITH NO COMPLICATIONS AND THE KYPHOPLASTY WAS RE-SCHEDULE FOR THE PATIENT AFTER AN APPROPRIATE RECOVERY TIME PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607709 OSSEOFLEX SN, STEERABLE NEEDLE 10GA WITH ACCESS KIT NEEDLE GAA OSSEON LLC OF-0020 040115-01

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention