BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW

    MDR report key: 2925923 · Received January 22, 2013

    Report

    Report Number
    2520274-2013-00545
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 28, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATE AND SCREW CONSTRUCT ON ((B)(6) 2012. PATIENT DEVELOPED POSSIBLE INFECTION AT IMPLANT SITE. SURGEON OPTED TO RETURN PATIENT TO OPERATING ROOM ON ((B)(6) 2012 FOR REMOVAL OF ALL HARDWARE. IT IS REPORTED PATIENT HAS POSSIBLE MALUNION. NO FURTHER INFORMATION IS AVAILABLE. THIS IS 2 OF 11 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31339 LOCKING SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention PLATE, SCREWS