BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4/2.7MM VA-LCP L-FUSION PL LONG/RIGHT

    MDR report key: 2854551 · Received December 3, 2012

    Report

    Report Number
    1719045-2012-01222
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 5, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K100776
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT. IMPLANTED APPROXIMATELY 9 MONTHS, (B)(6) 2012, OR 10 MONTHS, (B)(6) 2011, AGO. REVIEW OF THE RESPECTIVE RAW MATERIAL AND FINISHED PRODUCT DHR FILES FOUND NO IRREGULARITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    STERILIZATION VALIDATION DOCUMENTATION, DECISION FINDING PROTOCOLS, DFPS, WAS REVIEWED AND DEMONSTRATED THAT EACH OF THE PART NUMBERS INCLUDED WITHIN THIS COMPLAINT HAD BEEN EVALUATED FOR STERILIZATION. THE STERILIZATION PARAMETERS ARE CONSISTENT WITH SYNTHES CURRENT IFUS, AND THE SUPPORTING VALIDATIONS DEMONSTRATE THAT A STERILITY ASSURANCE LEVEL, SAL, OF 10, 6 IS ACHIEVABLE WHEN THE IFUS ARE EMPLOYED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED APPROXIMATELY 9 MONTHS, (B)(6) 2012, OR 10 MONTHS, (B)(6) 2011, AGO WITH PLATES AND SCREWS FOR A FOOT FUSION. IT WAS DETERMINED THE PATIENT DEVELOPED AN INFECTION, DATE UNKNOWN. SURGEON RETURNED THE PATIENT TO THE O.R. ON (B)(6) 2012; HARDWARE WAS REMOVED AND THE WOUND WAS CLEANED AND TREATED FOR INFECTION. SURGEON DID NOT REVISE THE PATIENT TO ANY NEW HARDWARE. HOSPITAL WILL NOT BE RETURNING THE PARTS. THIS IS 2 OF 19 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4/2.7MM VA-LCP L-FUSION PL LONG/RIGHT VA-LCP L-FUSION PLATE HRS SYNTHES MONUMENT 6614333

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATES, SCREWS