BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOMPOSITE INTER- FERENCE SCREW

    MDR report key: 3091994 · Received May 3, 2013

    Report

    Report Number
    1220246-2013-00065
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 8, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K071176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. THE MOST LIKELY CAUSE OF THIS TYPE OF EVENT IS DUE TO THE IMPLANT BEING PROUD AND /OR 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. IT ALSO STATES THAT UNDER INSERTION OF THE DEVICE MAY LEAVE THE PROXIMAL END OF THE IMPLANT PROTRUDING BEYOND THE CORTICAL BONE WHICH COULD POTENTIALLY CAUSE SOFT TISSUE IRRITATION AND/OR PAIN POST-OPERATIVELY. 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. PART REMAINS IN PATIENT.

    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

    IT WAS REPORTED THAT AFTER AN ACL PROCEDURE ON (B)(6) 2011, THE PATIENT BEGAN HAVING PROBLEMS WITH HIS KNEE POPPING AND CAUSING PAIN DURING HEAVY SPORTING ACTIVITY. IN EARLY (B)(6) 2013, HE HAD A FOLLOW UP EXAM WITH HIS SURGEON, AND IT WAS REVEALED THAT THE IMPLANT WAS SITTING PROUD IN THE BONE TUNNEL AND COULD BE SEEN UNDER THE SKIN. THE BIO-COMPOSITE IMPLANT HAD NOT BEEN FULLY ABSORBED; A CYST HAD FORMED IN THE BONE TUNNEL. THE CYST WAS DRAINED AND AREA WAS FLUSHED, SMALL LOOSE FRAGMENTS WERE REMOVED AND TISSUE WAS SENT OUT FOR TESTING. AN ALLOGRAFT WAS USED FOR THE PROCEDURE. PATIENT HAS A FOLLOW UP VISIT ON (B)(6) 2013 WITH AN ACL REVISION SCHEDULED ON (B)(6) 2013. THE PATIENT IS NOT A SMOKER, DIABETIC, OR HAVE ANY KNOWN ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193969 BIOCOMPOSITE INTER- FERENCE SCREW FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Other