BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2841239 · Received November 21, 2012

    Report

    Report Number
    2520274-2012-03280
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 25, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. DEVICE USED FOR TREATMENT. 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. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT HAD LUMBAR FUSION, LEVELS L3 TO L5, WITH CLICK X SYSTEM ON (B)(6) 2012. PATIENT WENT FOR FOLLOW UP, DATE UNKNOWN, COMPLAINING OF PAIN. X-RAYS SHOWED THE LEFT SIDE ROD HAD MOVED OUT OF PLACE, NONUNION, AND THE RIGHT SIDE OF CONSTRUCT WAS STILL IN PLACE. PATIENT RETURNED TO OR ON (B)(6) 2012, HARDWARE WAS REMOVED, PATIENT REVISED WITH NEW CLICK X CONSTRUCT. THE PROCEDURE WAS COMPLETED. THIS IS 2 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention ROD, SCREW, LOCKING CAP