BEUDAMED
    FDA Adverse Event Death Summary report: N

    2520274-2013-02384

    MDR report key: 3095511 · Received May 7, 2013

    Report

    Report Number
    2520274-2013-02384
    Event Type
    Death
    Date Received
    May 7, 2013
    Report Date
    April 9, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: ON (B)(6) 2012, A PATIENT UNDERWENT SURGERY FOR A BILATERAL DISTAL FEMUR FRACTURE. THE LESS INVASIVE STABILIZATION SYSTEM (LISS) WAS USED. THE PIN TRACK WOUND BECAME INFECTED. THE PLATE AND SCREW WAS REMOVED AND REPLACED WITH THE EX-FIX DURING A REVISION SURGERY ON AN UNKNOWN DATE. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE PATIENT PASSED AWAY ON AN UNKNOWN DATE IN THE (B)(6) 2013. IT WAS REPORTED THAT THE MULTI ORGAN IMPAIRMENT WAS NOT DIRECTLY RELATED TO SEPSIS, BUT DUE TO PRE INJURY MEDICAL COMORBIDITIES, MORBID OBESITY, AND RESTRICTION TO BED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198702 KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention