BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4231438 · Received November 6, 2014

    Report

    Report Number
    2520274-2014-14533
    Event Type
    Injury
    Date Received
    November 6, 2014
    Report Date
    October 14, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR TWO DUAL CORE LOCKING SCREWS/UNKNOWN LOTS. 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 A RIGHT TIBIAL NAIL REVISION SURGERY WAS PERFORMED ON (B)(6), 2014 DUE TO PATIENT COMPLAINTS OF PAIN WITH NO ALLEGATION AGAINST THE IMPLANTS. THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6), 2013. THE TIBIAL NAIL AND SIX SCREWS (2 DUAL CORE LOCKING AND 4 LOCKING) WERE REMOVED INTACT WITH NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR TWO DUAL CORE LOCKING SCREWS. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714016 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention