BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K-WIRE

    MDR report key: 2801775 · Received October 16, 2012

    Report

    Report Number
    MW5027280
    Event Type
    Injury
    Date Received
    October 16, 2012
    Date of Event
    May 24, 2012
    Report Date
    August 7, 2012
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RTI BIOLOGICS, INC. (RTI) HAS INITIATED AN INVESTIGATION REPORTED ON (B)(6) 2012, FOR A COMPLAINT OF A POSSIBLE POST-OPERATIVE INFECTION. ON (B)(6) 2012, THE PT UNDERWENT A RECONSTRUCTION OF THE ANTERIOR CRUCIATE LIGAMENT AND REC'D AN RTI BIOCLEANSE POSTERIOR TIBIALIS TENDON. PT PRESENTS WITH SWELLING AND PAIN ON (B)(6) 2012, THE PT'S KNEE IS ASPIRATED AND SENT FOR CULTURES. THE GRAFT IS REMOVED ON (B)(6) 2012. DONOR AND MFG RECORDS ARE RE-REVIEWED AS PART OF RTI'S INVESTIGATION. NO DEVIATIONS WERE NOTED FOR THE DONOR AND ALL RTI DONOR ELIGIBILITY REQUIREMENTS WERE MET. INITIAL RPTR: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 K-WIRE K-WIRE HTY
    2 INTRAFIT SCREW SCREW HWC
    3 RIGIDFIX PINS PIN MAI

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other POSTERIOR TIBIALIS TENDON, LOT 101077588,| EXP DATE 6/22/2015, ID (B)(4)| IMPLANT: