BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STREAMLINE MIS PEDICLE SCREW SYSTEM

    MDR report key: 4102599 · Received August 28, 2014

    Report

    Report Number
    1833824-2014-00018
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 28, 2014
    Manufacturer
    PIONEER SURGICAL
    Product Code
    NKB
    PMA / PMN Number
    K130286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED FOR EVALUATION AND SINCE NO LOT NUMBER WAS KNOWN THE DHR WAS NOT ABLE TO BE REVIEWED. THE PATIENT HAS NOT BEEN REVISED AT THIS TIME AND THERE IS NO PLANS TO REVISE ACCORDING TO THE SURGEON. X-RAYS WERE REVIEWED AND NO CAUSE COULD BE DETERMINED. NO MORE INFORMATION IS KNOWN AT THIS TIME. IF MORE INFORMATION BECOMES AVAILABLE PIONEER SURGICAL WILL UPDATE THIS REPORT.

    Description of Event or Problem · 1

    PATIENT UNDERWENT A SPINAL FUSION PROCEDURE (L4-S1) ON (B)(6) 2014. IN A FOLLOW UP VISIT (APPROXIMATELY 2 WEEKS AFTER INITIAL SURGERY) IT WAS FOUND THAT ONE OF THE PEDICLE SCREWS AT THE S1 LOCATION HAD DISASSOCIATED. PATIENT WAS ASYMPTOMATIC AND THE SURGEON DID NOT HAVE ANY PLANS TO REVISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523862 STREAMLINE MIS PEDICLE SCREW SYSTEM MIS PEDICLE SCREW NKB PIONEER SURGICAL UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR