BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES LOCKING PLATE/8 SCREWS

    MDR report key: 3224525 · Received October 18, 2012

    Report

    Report Number
    3224525
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 16, 2012
    Manufacturer
    SYNTHES, INC.
    Product Code
    DZL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD SURGERY ON HER RIGHT ANKLE (B)(6) 2012, FOR "BURSITIS SECONDARY TO DEEP IMPLANT" FROM A PREVIOUS IMPLANTATION OF THE HARDWARE (B)(6) 2010. THE PATIENT HAD THE PROCEDURE OF "OPEN REDUCTION INTERNAL FIXATION RIGHT ANKLE TRIMALLEOLAR FRACTURE". DURING THE PROCEDURE 2 CORTICAL SCREWS WERE PLACED OBLIQUELY ACROSS THE FRACTURE MAINTAINING ANATOMIC REDUCTION. THE FIBULA FRACTURE WAS EXPOSED AND REDUCED ANATOMICALLY AND A 6-HOLE LOCKING PLATE WAS APPLIED USING A COMBINATION OF BOTH LOCKING AND UNLOCKING SCREWS. THE SURGERY WAS REPORTED AS NO COMPLICATIONS. ON (B)(6) 2012, THE PATIENT CHOSE ELECTIVE SURGERY TO REMOVE THE HARDWARE AND SCREWS RELATED TO BURSITIS SECONDARY TO THE DEEP IMPLANT. TOTAL OF 8 SCREWS AND THE LOCKING PLATE WERE REMOVED. AFTER REMOVAL OF THE TWO SMALL FRAGMENT SCREWS, THE SCREWS WERE NOTED BY THE SURGEON TO BE BROKEN. THE INTRAOSSEOUS METALLIC SEGMENTS OF THE SCREWS WERE NOT REMOVED BY THE SURGEON. AFTER REMOVED OF THE OTHER SCREWS, THERE WAS THE SYNDESMOSIS SCREW THAT WAS PREVIOUSLY NOTED TO BE BROKEN AND THIS WAS NOT REMOVED. THE SURGEON THEN RONGEURED THE SCREW HOLES AND CLOSED THE WOUND WITH A DRESSING APPLIED. THE PLATE AND 8 TOTAL SCREWS WERE REMOVED. REFERENCE MANUFACTURER REPORT # 2520274-2012-02314.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES LOCKING PLATE/8 SCREWS LOCKING PLATE AND SCREWS DZL SYNTHES, INC. 223561 UK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| R