BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

    MDR report key: 3754022 · Received April 16, 2014

    Report

    Report Number
    2520274-2014-10859
    Event Type
    Injury
    Date Received
    April 16, 2014
    Report Date
    April 1, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    KTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT FOR DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN EXPERT TIBIAL NAIL. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ATTAL, R., ET. AL., (2012, MARCH), A MULTICENTRE CASE SERIES OF TIBIA FRACTURES TREATED WITH THE EXPERT TIBIA NAIL., ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, 132, 975-984. THE AIM OF THIS STUDY WAS TO PRESENT CLINICAL EXPERIENCE AND OUTCOMES OF INTRAMEDULLARY NAILING OF PROXIMAL, MIDSHAFT AND DISTAL TIBIA FRACTURES WITH THE EXPERT TIBIA NAIL FROM SYNTHES, AN IMPLANT OFFERING A WIDE RANGE OF PROXIMAL AND DISTAL LOCKING OPTIONS IN MULTIPLE PLANES TO INCREASE STABILITY OF THE IMPLANT AND BONE CONSTRUCT. THERE WERE 180 PATIENTS WITH 185 TIBIA FRACTURES THAT WERE FOLLOWED BETWEEN (B)(6) 2004 AND (B)(6) 2005. THERE WERE 68 FEMALES AND 111 MALES (B)(6). FOLLOW-UPS WERE DONE AT 12 WEEKS AND ONE YEAR. IT WAS REPORTED THAT THERE WERE OSTEOMYELITIS, LOSS OF REDUCTION, DELAYED UNION, AND SCREW/BOLT BREAKAGE. THE AUTHOR CONCLUDED THAT INTRAMEDULLARY EXPERT TIBIA NAIL FIXATION OF TIBIA FRACTURES RESULTS IN LOW RATES OF DELAYED UNION, PRIMARY AND SECONDARY MALALIGNMENT, IMPLANT-RELATED COMPLICATIONS, AND SECONDARY SURGERY. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. REVISION SURGERY WITH A LOCKING COMPRESSION PLATE AND FIBULA OSTEOTOMY WAS UNDERTAKEN FOR ONE MALALIGNMENT CASE 3 OF 3 MEDWATCHES A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232975 APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT KTT SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention