BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 3870539 · Received June 12, 2014

    Report

    Report Number
    2520274-2014-11810
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    May 16, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR 1 UNKNOWN LOCKING SCREW/UNKNOWN LOT. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HARDWARE WAS REMOVED DUE TO COMPLAINTS OF PATIENT PAIN. AFTER THE HARDWARE WAS REMOVED, IT WAS NOTED THAT ONE OF THE FOUR LOCKING SCREWS WAS BROKEN. ALL HARDWARE WAS REMOVED AND NOTHING WAS LEFT IN THE PATIENT. IT WAS ALSO NOTED THAT THERE WAS COMPLETE HEALING OF THE PREVIOUS INJURY AND THE PATIENT STATUS WAS REPORTED AS FINE. THIS REPORT IS FOR ONE UNKNOWN LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348402 SCREW,FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention