BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOMPOSITE INTERFERENCE SCREW W/ DISP SHEATH

    MDR report key: 4091198 · Received September 16, 2014

    Report

    Report Number
    1220246-2014-00165
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K071176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (DATE OF BIRTH, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. LOT NUMBER WAS NOT PROVIDED, SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE(S) OF THIS EVENT IS AN ADVERSE REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED. PRODUCT DIRECTIONS FOR USE WARNS OF ADVERSE EFFECTS LIKE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS AS WELL AS INFECTIONS BOTH DEEP AND SUPERFICIAL TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS PRESENTED TO THE SURGEON WITH KNEE PAIN. ORIGINAL SURGERY (B)(6) 2012. DURING THE SECOND SURGERY, THE SURGEON NOTED A MILKY FLUID ON THE TIBIAL PORTION NEAR THE IMPLANT. THERE WAS ALSO A MASS FOUND IN FRONT OF THE TIBIAL IMPLANT. THE SURGEON REMOVED THE MASS AND THE REMAINDER OF THE BIO-COMPOSITE IMPLANT. THE SURGEON NOTED THAT THE BIO-COMPOSITE IMPLANT ON THE FEMUR SIDE APPEARED TO BE INTACT. THERE WAS NO NEED FOR ANY ADDITIONAL IMPLANT AS THE SURGEON REPORTED THE LIGAMENT APPEARED IN-TACT. THE PATIENT WAS RELEASED IN STABLE CONDITION. THE IMPLANT PARTICLES THAT WERE REMOVED FROM THE PATIENT WERE SENT FOR TESTING. AT THE TIME OF THIS INITIAL REPORT, THE RESULTS WERE NOT YET AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573747 BIOCOMPOSITE INTERFERENCE SCREW W/ DISP SHEATH FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other