BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM/3.5MM LCP LATERAL DISTALFIBULA PLATE 6H/RIGHT/

    MDR report key: 2192008 · Received July 28, 2011

    Report

    Report Number
    3003506883-2011-00506
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    March 14, 2011
    Report Date
    June 29, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K083213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. ADDITIONAL INFO FROM THE USER FACILITY REPORT: (B)(6) 2011, SYNTHES LATERAL DISTAL FIBULA LOCKING PLATE, FIBULA PLATE - (R), SYNTHES (B)(4).

    Description of Event or Problem · 1

    PT UNDERWENT ORIF BIMALLEOLAR LEFT ANKLE FRACTURE REPAIR ON (B)(6) 2010 WITH INSERTION OF HARDWARE. PT HAD NO KNOWN ALLERGIES AT THIS TIME. PT DEVELOPED A SMALL WOUND DEHISCENCE IN (B)(6) 2011 AND WAS HOSPITALIZED FOR INCISION AND DRAINAGE AND WOUND DEBRIDEMENT WITH APPLICATION OF A WOUND VAC. PT WAS REFERRED TO AN ALLERGIST WHO IDENTIFIED THE PT HAS A NEW ALLERGY TO NICKEL. PT PRESENTS TO OPERATING ROOM ON (B)(6) 2011 FOR REMOVAL OF HARDWARE ON MEDIAL AND LATERAL SIDES OF LEFT ANKLE. SURGERY: INCISION AND DÉBRIDEMENT, HARDWARE REMOVAL OF LEFT ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.7MM/3.5MM LCP LATERAL DISTALFIBULA PLATE 6H/RIGHT/ LCP LATERAL DISTAL FIBULA PLATE HRS SYNTHES ELMIRA 02.112.142 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention