BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOMPOSITE INTER- FERENCE SCREW, 9 X 23MM

    MDR report key: 2260456 · Received September 22, 2011

    Report

    Report Number
    1220246-2011-00157
    Event Type
    Injury
    Date Received
    September 22, 2011
    Date of Event
    May 1, 2009
    Report Date
    August 26, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K071176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    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. THIS IS THE SECOND 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 INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ACHILLES ALLOGRAFT PATIENT HAD PAIN THAT STARTED AT ABOUT 2 YEARS OUT FROM SURGERY WHICH RESULTED IN THE MRI FOLLOWED BY SCREW REMOVAL. ON THE MRI, THERE WAS EDEMA AROUND THE SCREW AND THE THREADS WERE VISIBLE. SURGEON CUT INTO THE TUNNEL WITH THE BOVI TO FIND A MILKY WHITE FLUID CAMEOUT OF THE TUNNEL. PATIENT WAS FLUSHED AND A CULTURE WAS TAKEN (RESULTS OF CULTURE UNKNOWN AT THIS TIME).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCOMPOSITE INTER- FERENCE SCREW, 9 X 23MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 177862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other