BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3935302 · Received July 15, 2014

    Report

    Report Number
    2520274-2014-12522
    Event Type
    Injury
    Date Received
    July 15, 2014
    Report Date
    June 17, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). 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 REVISION SURGERY OCCURRED ON (B)(6) 2014 DUE TO A NONUNION AND BREAKAGE OF A 2.7MM/35MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (LCP) ANTEROLATERAL DISTAL TIBIA PLATE AT THE POINT BETWEEN THE GROUPS OF 2.7MM AND 3.5MM SCREW HOLES. THE INITIAL TIBIA PLATING PROCEDURE OCCURRED ON AN UNKNOWN DATE IN 2014. ABOUT 3-4 MONTHS AFTER THE INITIAL PROCEDURE, THE PATIENT REPORTED OF PAIN. THE SURGEON EXPLANTED THE BROKEN PLATE AND 8 INTACT SCREWS (SEVEN 2.7MM/35MM LOCKING SCREWS AND ONE 3.5MM CORTEX SCREW). AN INFECTION WAS ALSO IDENTIFIED AND THE SURGEON IMPLANTED AN ANTIBIOTIC SPACER. ONCE THE INFECTION HAS HEALED, A PLANNED REVISION WITH A LONGER PLATE WILL TAKE PLACE. ALL DEVICES WERE SUCCESSFULLY EXPLANTED, AS CONFIRMED THROUGH INTRAOPERATIVE AND POSTOPERATIVE X-RAYS. THERE WAS NO PATIENT HARM OR SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE UNKNOWN 3.5MM CORTEX SCREW. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413690 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention