BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANNULATED SCREW

    MDR report key: 2854192 · Received December 3, 2012

    Report

    Report Number
    2520274-2012-03476
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 4, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO PART OR LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING THE REMOVAL OF A PLATE. THE SURGEON ELECTED TO REMOVE THE PLATE TO REPLACE IT WITH A TOTAL KNEE. THE PATIENT HAD PAIN AND THE SURGEON DETERMINED A TOTAL KNEE REPLACEMENT WOULD BE THE BEST OPTION FOR THE PATIENT. REPORTEDLY, NONE OF THE DEVICES REMOVED DURING THE EXPLANT HAD FAILED. THIS IS REPORT # 4 OF 10 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED SCREW CANNULATED SCREW HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention