BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD

    MDR report key: 2820765 · Received November 6, 2012

    Report

    Report Number
    2520274-2012-02926
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PATIENT HAD POSTERIOR INSTRUMENTATION FROM L1 -ILIUM. COMBINATION OF USS DUAL OPENING AND MATRIX. PATIENT DEVELOPED KYPHOSIS ABOVE THE CONSTRUCT AND CONSTRUCT WAS PULLING OUT OF THE PEDICLE /VERTEBRAL BODY AT L1 AND L2. THE SURGEON REVISED THE PATIENT ON (B)(6) 2012 AND REMOVED THE LEFT L1 AND L2 SCREWS, AND THE RIGHT L1 SCREW. THE CONSTRUCT WAS EXTENDED TO T10 USING USS DUAL OPENING. NEW RODS WERE CONNECTED TO THE EXISTING CONSTRUCT. THIS REPORT IS #4 OF 5 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROD ROD HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention SCREWS, RODS