BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI END CAP T40 STRDRV 0MM EXT

    MDR report key: 3778061 · Received April 29, 2014

    Report

    Report Number
    2520274-2014-11119
    Event Type
    Injury
    Date Received
    April 29, 2014
    Report Date
    April 1, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    PMA / PMN Number
    PK033618
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAME HWC. 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HARDWARE REMOVAL DUE TO A NONUNION/ MALUNION OF THE DISTAL FEMUR. THE PATIENT FRACTURED HER FEMUR ON (B)(6), 2013 AND ON (B)(6), 2013 THE FRACTURE WAS TREATED WITH A TITANIUM CANNULATED RETROGRADE/ANTEGRADE FEMORAL NAIL. THE PATIENT RETURNED TO THE OPERATING ROOM FOR A HARDWARE REMOVAL AND CORRECTION OF ALIGNMENT WITH A 4.5 VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) CURVED CONDYLAR PLATE. THERE WAS NO REPORTED DELAY IN THE PROCEDURE OR PATIENT HARM. THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257764 TI END CAP T40 STRDRV 0MM EXT ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention