BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP MEDIAL DISTAL TIBIAPLATE W/O TAB 8 HOLES-LEFT

    MDR report key: 3181591 · Received June 21, 2013

    Report

    Report Number
    3003506883-2013-00265
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K013248
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH MEDIAL DISTAL TIBIA PLATE AND SCREWS FOR COMMINUTED DISTAL TIBIA FRACTURE ON UNKNOWN DATE. DURING A FOLLOW-UP VISIT SURGEON DISCOVERED THREE OF THE PROXIMAL 3.5MM LOCKING SCREWS AND ONE OF THE PROXIMAL 3.5MM CORTEX SCREWS WERE BROKEN. SURGEON ALSO NOTED A NON-UNION OF THE TIBIA. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 WHERE SURGEON REMOVED THE INTACT PLATE, SIX INTACT SCREWS, AND FOUR BROKEN SCREW HEADS. THE FOUR BROKEN SCREW SHAFTS REMAIN IMPLANTED IN PATIENT BONE. PATIENT WAS REVISED TO ILIAC CREST BONE GRAFT, DBX BONE PUTTY, AND A LONGER PLATE AND SCREWS. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282262 3.5MM LCP MEDIAL DISTAL TIBIAPLATE W/O TAB 8 HOLES-LEFT HRS SYNTHES ELMIRA 6984438

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention