BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04176

    MDR report key: 3223301 · Received July 12, 2013

    Report

    Report Number
    2520274-2013-04176
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 13, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    CONSULTANT REPORTS THAT DURING A PROCEDURE TO REMOVE A DISTAL FEMUR PLATE, TWO SCREW HEADS WERE STRIPPED. THE SURGEON HAD TO CUT OFF THE HEADS OF THE SCREWS IN ORDER TO REMOVE THE HARDWARE. THIS RESULTED IN A ONE HOUR DELAY TO THE PROCEDURE. THE HARDWARE WAS IMPLANTED IN (B)(6) 2011 TO CORRECT A DISTAL FEMUR DEFORMITY. THIS WAS A SCHEDULED PROCEDURE FOR REMOVAL OF HARDWARE FOLLOWING SUCCESSFUL HEALING OF THE PATIENT. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4) AND IS FOR AN UNKNOWN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321973 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention