BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-COMP. INTERFERENCE SCREW, FULL THREAD

    MDR report key: 2822282 · Received May 29, 2012

    Report

    Report Number
    1220246-2012-00101
    Event Type
    Injury
    Date Received
    May 29, 2012
    Date of Event
    May 8, 2009
    Report Date
    May 7, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K071176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED, BUT NOT PROVIDED. NO FURTHER PT INFO WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE OF F/U COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVAL, BUT WAS NOT RETURNED, THEREFORE THE COMPLAINT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVAL. DEVICE HISTORY RECORD REVEALED NOTHING RELEVANT TO THIS EVENT. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS AN ADVERSE REACTION OF THE PT TO THE MATERIAL(S) IMPLANTED. PRODUCT DIRECTIONS FOR USE WARNS OF POSSIBLE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS TO THE IMPLANT MATERIALS. PT 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 CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFO IS RECEIVED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT WAS REPORTED THAT SCREW WAS IMPLANTED ON (B)(6) 2009. SCREW REMOVED DUE TO LOCALIZED INFLAMMATORY RESPONSES AND PAIN AT DISTAL END OF TIBIAL TUNNEL. TISSUE INFLAMMATION. SCREW HAD DISSOLVED INTO A MUSHY TYPE SUBSTANCE RESEMBLING TOOTHPASTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-COMP. INTERFERENCE SCREW, FULL THREAD FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 200268

    Patients

    Seq Age Sex Outcome Treatment
    1 Other