BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOMPOSITE INTER- FERENCE SCREW

    MDR report key: 2072445 · Received April 29, 2011

    Report

    Report Number
    1220246-2011-00065
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    February 4, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K071176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS AN ADVERSE REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED. PRODUCT DIRECTIONS FOR USE WARNS OF POSSIBLE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. 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. PER CUSTOMER, NOT RETURNING DEVICE.

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW-UP SUBMISSION TO REFLECT A CHANGE OF THE DEVICE CATALOG NUMBER FROM THE ORIGINAL SUBMISSION. DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    ALLERGIC REACTION; POST OP ONE DAY. REDNESS, WARMTH, SWELLING, INORDINATE PAIN, ALL BILATERAL. HAMMERTOE CASE. IMPLANTS REMOVED (B)(6) 2011. CURRENT MEDICATIONS: ADVAIR INHALER, PROAIR INHALER, ALLEGRA, NEXIUM, LAMISIL, VITAMIN B12, VITAMIN E (INSTRUCTED TO STOP). MODERATE PATIENT ACTIVITY, CURRENT CONDITION STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCOMPOSITE INTER- FERENCE SCREW FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 309787

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-1588T, LOT 403195, ACL TIGHTROPE