BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTPIN

    MDR report key: 947720 · Received November 7, 2007

    Report

    Report Number
    9613278-2007-00043
    Event Type
    Other
    Date Received
    November 7, 2007
    Report Date
    October 9, 2007
    Manufacturer
    CONMED LINVATEC BIOMATERIALS LTD.
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO WE HAVE RECEIVED ABOUT THIS CASE, CONCLUSIONS ABOUT THE CAUSE OF THE PROBLEMS CANNOT BE IDENTIFIED. WE HAVE REQUESTED ADD'L INFO FROM THE HOSPITAL. WE WILL FOLLOW UP THIS REPORT ACCORDINGLY IF WE RECEIVE ADD'L INFO.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED, THAT A PT AT CFH HOSPITAL HAD AN ALLERGIC REACTION FROM THIS DEVICE. PT FEMALE WHO HAD ARTHROPLASTY ON THE 3RD AND 4TH TOES OF LEFT FOOT IN 2007. ABOUT 1 WEEK LATER, SHE STARTED TO HAVE PAIN AND SWELLING AND DEVELOPED CELLULITIS. DR. PLACED THE PT ON ANTIBIOTIC TREATMENT (AMOXICILLIN, RELOFIN AND CIPRO) AND THE SWELLING AND REDNESS DECREASED FOLLOWING ANTIBIOTIC THERAPY. AS OF THE FOLLOWING FOURTEEN DAYS, THE SMARTPIN REMAINED IMPLANTED. IT WAS REPORTED THAT THE DR. USES OUR TOOLS TO INSERT THE SMARTPIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTPIN BIOABSORBABLE BONE FIXATION DEVICE MAI CONMED LINVATEC BIOMATERIALS LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention