BEUDAMED
    FDA Adverse Event Injury Summary report: N

    END CAP, SCN T2 SCN

    MDR report key: 3007609 · Received March 15, 2013

    Report

    Report Number
    0009610622-2013-00126
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    October 15, 2012
    Report Date
    February 21, 2013
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K023267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE NAIL WAS NOT RETURNED FOR EVALUATION. ACCORDING TO RECEIVED INFORMATION THE NAIL WAS DISCARDED. AN INFECTION ISSUE WAS SUSPECTED AFTER AN IMPLANTATION PERIOD OF APPROX. 1 MONTH. A CUSTOMER CHECKLIST REQUESTING INFORMATION REGARDING THE LOCAL ENVIRONMENT, WHICH WAS SENT IMMEDIATELY BY THE MANUFACTURER ON FEBRUARY 22, 2013 WAS RETURNED ON MARCH 12, 2013. WE RECEIVED THE INFORMATION THAT THE PATIENT SUFFERED FROM (B)(6) AND (B)(6). NO SPECIFIC EXAMINATION IN ORDER TO IDENTIFY THE KIND AND THE ORIGIN OF POTENTIAL PATHOGENICS AND / OR ORGANISM. THE PACKAGING AND THE STERILIZATION PROCEDURES WERE REVIEWED WITHOUT ANY OBSERVATIONS. INVESTIGATION REVEALED THAT THE NAIL WAS STERILE AT THE TIME OF DISTRIBUTION. REVIEW OF COMPLAINT HISTORY, CAPA DATABASES AND RISK ANALYSIS DID NOT IDENTIFY ANY CONSPICUITY. THERE WERE NO OPEN ACTION ITEMS RELATED TO THE REPORTED EVENT FOR THE PRODUCT. NO NONCONFORMITY WAS IDENTIFIED. A CORRELATION BETWEEN THE ALLEGED INFECTION AND THE PRODUCT COULD NOT BE VERIFIED BASED ON THE ACTUAL STATUS OF INFORMATION.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, T2SCN SURGERY WAS PERFORMED. ON (B)(6) 2012, THE PATIENT DIED BY INFECTION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, T2SCN SURGERY WAS PERFORMED. ON (B)(6) 2012, THE PATIENT DIED BY INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108714 END CAP, SCN T2 SCN IMPLANT HSB STRYKER TRAUMA KIEL K122158

    Patients

    Seq Age Sex Outcome Treatment
    1 Death