BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOW PROFILE SCREW, TI, 4.5 X 45MM, CANNULATED

    MDR report key: 2070093 · Received April 27, 2011

    Report

    Report Number
    1220246-2011-00064
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    PMA / PMN Number
    K052614
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS AN ADVERSE REACTION OF THE PATIENT TO THE ARTHREX MATERIAL(S) IMPLANTED AS WELL AS THE CADAVER BONE AND TITANIUM SCREWS THAT CAME FROM ANOTHER SOURCE AND WERE ALSO USED AS PART OF THE TOTAL FOOT RECONSTRUCTION. PRODUCT DIRECTIONS FOR USE FOR THE ARTHREX DEVICE WARNS OF POSSIBLE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. OTHER: DEVICE REMAINS IN PATIENT.

    Description of Event or Problem · 1

    PATIENT HAVING AN ALLERGIC REACTION POSSIBLY RELATED TO SURGERY OF (B)(6) 2011. PATIENT'S HUSBAND CALLED THE DISTRIBUTOR REQUESTING INFO FOR THE ALLERGIST; THEY ARE REQUESTING A SAMPLE OF ALL IMPLANTS FOR ALLERGY TESTING. PATIENT HAS HAD REACTION SINCE THE DAY AFTER THE SURGERY; HIVES, SWOLLEN FACE AND TONGUE, SURGICAL SITE. HAS BEEN GIVEN PAIN MEDS AND STEROIDS. PATIENT IS NOT ALLERGIC TO ANYTHING, NOT LACTOSE INTOLERANT, NO DIABETES, NO SMOKING, LAB WORK WAS DONE ON THYROID (RESULTS OK), CURRENTLY ON MEDICATIONS ALLEGRA AND DEXILANT. AT TIME OF SURGERY, CADAVER BONE AND TITANIUM SCREWS WERE ALSO USED. PATIENT'S SURGERY WAS A TOTAL FOOT RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW PROFILE SCREW, TI, 4.5 X 45MM, CANNULATED PLATE, FIXATION, BONE HRS ARTHREX, INC. 407176

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other (B)(4) LOT 351824| (B)(4) LOT 31356