BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL INTRAFIX SCREW & SHEATH SYSTEM, 10MM

    MDR report key: 1924462 · Received December 7, 2010

    Report

    Report Number
    1221934-2010-00451
    Event Type
    Injury
    Date Received
    December 7, 2010
    Date of Event
    December 4, 2010
    Report Date
    December 3, 2010
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING THAT A PT UNDERWENT A SUCCESSFUL ARTHROSCOPIC ACL REPAIR ON (B)(6)2010. SOME TIME SUBSEQUENTLY, THE PT PRESENTED WITH AN INFECTION. A RE-SURGERY WAS PERFORMED ON (B)(6) 2010. AT THIS RE-SURGERY THE SURGEON REMOVED THE FIXATION DEVICE AND THE ALLOGRAFT (RTI). THE SURGEON DID NOT RE-FIXATE; IS TREATING THE PT WITH ANTIBIOTICS AND WILL RESCHEDULE A 3RD PROCEDURE FOR REMEDY WHEN THE INFECTION IS CLEAR. QUESTIONS ARE OUT FOR FURTHER DETAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL INTRAFIX SCREW & SHEATH SYSTEM, 10MM SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK 254685 3442815

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention