BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 3910446 · Received July 2, 2014

    Report

    Report Number
    2520274-2014-12353
    Event Type
    Injury
    Date Received
    July 2, 2014
    Report Date
    June 4, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN TIBIAL NAIL. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 A PATIENT EXPERIENCED A POTENTIAL ALLERGIC REACTION TO A TIBIAL NAIL. THE PATIENT'S DAUGHTER REPORTS THE PATIENT WAS TREATED WITH A TIBIAL NAIL FOR A LEG INJURY DUE TO AN AUTO ACCIDENT ON (B)(6) 2013. IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2013 THE PATIENT EXPERIENCED A BLISTERY RASH THAT STARTED AROUND THE LEG OF THE IMPLANT SITE AND PROGRESSED ALL OVER THE BODY. THE PATIENT HAS UNDERGONE A SERIES OF TESTING WITH THE MOST RECENT BEING A PATCH TESTING BY AN ALLERGIST. THE TESTING INDICATED A POSITIVE REACTION TO COBALT. IT WAS ALSO REPORTED THAT PATIENT HAS BEEN TREATED WITH SEVERAL DIFFERENT SALVES PRESCRIBED BY A DERMATOLOGIST AND THE PATIENT IS BEING TESTED FOR ALLERGIC REACTION FOR THE COMPONENTS OF THE MEDICATIONS AS WELL. THE SALVES HAVE CLEARED SOME AREAS BUT RASH RETURNS IN SPECIFIC PLACES (I.E. AROUND THE ANKLE). THERE ARE NO PLANS FOR EXPLANT SURGERY. THIS REPORT IS FOR AN UNKNOWN TIBIAL NAIL. THIS REPORT IS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387901 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention