BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-02685

    MDR report key: 3123811 · Received May 22, 2013

    Report

    Report Number
    2520274-2013-02685
    Event Type
    Injury
    Date Received
    May 22, 2013
    Report Date
    April 24, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A ROD SLIPPED OUT OF A SCREW HEAD OF A MATRIX SPINE CONSTRUCT. THE MATRIX WAS ORIGINALLY IMPLANTED DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE ON AN UNKNOWN DATE. THE SURGEON REVISED THE PATIENT ON AN UNKNOWN DATE. HE REPLACED THE SLIPPED ROD WITH A LONGER ROD AS THE ORIGINAL ROD DID NOT EXTEND PAST THE SCREW HEAD. HE ALSO REPLACED THE LOCKING CAP WHERE THE SLIPPAGE OCCURRED. THE SCREW AT THE SLIPPAGE LOCATION WAS ABLE TO REMAIN IN THE PATIENT. THIS REPORT IS FOR ONE ROD OF UNKNOWN PART NUMBER AND UNKNOWN LOT NUMBER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225791 NKB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention