BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-01916

    MDR report key: 3052092 · Received April 11, 2013

    Report

    Report Number
    2520274-2013-01916
    Event Type
    Injury
    Date Received
    April 11, 2013
    Report Date
    March 18, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DEVICE WAS IMPLANTED IN 1998. INITIAL REPORT INCORRECTLY STATED DATE OF IMPLANT AS 1999. (B)(4). HEALTH PROFESSIONAL ONLY. INITIAL REPORT INCORRECTLY STATED COMPANY REPRESENTATIVE ALSO.

    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

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A FEMORAL NAIL AND INTERLOCK SCREW CONSTRUCT IN 1999 DUE TO A FEMORAL SHAFT FRACTURE WHICH WAS THE RESULT FROM A CAR ACCIDENT IN 1998. IN 2007 IMAGING REVEALED FEMORAL NONUNION. DURING THIS TIME THE PATIENT UTILIZED A CRUTCH AND A CANE ALL THE WHILE EXPERIENCING UNSPECIFIED CONSISTENT PAIN AS WELL AS BACK PAIN. ON (B)(6) 2013 IMAGING REVEALED RIGHT MIDSHAFT FEMORAL FRACTURE NONUNION, IM NAIL, AND 3 BROKEN INTERLOCK SCREWS. ONE SCREW WAS BROKEN PROXIMALLY AND 2 SCREWS WERE BROKEN DISTALLY. AS A RESULT OF THIS THE PATIENT ELECTED TO HAVE THE FEMORAL NAIL CONSTRUCT REMOVED. THE PATIENT RETURNED TO THE OR AND THE IM NAIL AND THE THREE INTERLOCK SCREW HEADS WERE REMOVED. THE FRAGMENTED PORTION OF ONE SCREW WAS REMOVED AND THE OTHER TWO FRAGMENTED PORTIONS WERE LEFT IN PLACE IN THE PATIENT SINCE IT WAS REPORTEDLY IN SAFE POSITIONS. THIS REPORT IS FOR A UNK - SCREW. THIS IS 3 OF 4 PARTS REPORTED FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155450 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention