BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM LCP(TM) CONDYLAR PLATE 7 HOLES SHAFT

    MDR report key: 3121554 · Received May 21, 2013

    Report

    Report Number
    8030965-2013-02274
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 23, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K063049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, THE PATIENT WAS IMPLANTED WITH HARDWARE IN THE LEFT FOOT. THE PATIENT DEVELOPED PAIN ON AN UNKNOWN DATE. REVISION SURGERY TOOK PLACE ON (B)(6) 2013 TO REMOVE THE PAINFUL HARDWARE. A BROKEN PLATE, SCREWS, AND PENTACAL SCREWS WERE REMOVED. THE FRACTURE HAD HEALED. A 2.7MM LOCKING SCREW AND A 2.7MM CORTEX SCREW WERE FOUND TO BOTH HAVE THE HEAD REMOVED. THE SHAFTS OF BOTH SCREWS REMAIN IMPLANTED. THIS IS REPORT 1 OF 10 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224800 2.7MM LCP(TM) CONDYLAR PLATE 7 HOLES SHAFT HRS SYNTHES GMBH 3812321

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention