BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-COMP INTERF SCREW CANN DELTA TAP 11 X 35MM

    MDR report key: 3061113 · Received April 16, 2013

    Report

    Report Number
    1220246-2013-00053
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    December 14, 2010
    Report Date
    March 20, 2013
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K071176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. 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 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 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. 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 REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. DEVICE WAS DISCARDED BY THE FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO IMPLANT BREAKING DOWN. ON (B)(6) 2010, PATIENT HAD AN ACL WITH A MENISCAL REPAIR DONE. 5-6 MONTHS POST-OP, PATIENT BEGAN TO HAVE PAINFUL SWELLING WITH A KNOT DEVELOPING UNDER THE KNEE CAP. PATIENT RECEIVED CORTISONE SHOTS AND PAIN MEDICATION. THE KNOT BECAME THE SIZE OF A GOLF BALL. ON (B)(6) 2013, PIECES OF THE IMPLANT ALONG WITH A WHITE MILKY SUBSTANCE WERE FLUSHED AND REMOVED FROM THE ACL TUNNEL. THE TENDON REMAINED ATTACHED. NO NEW IMPLANTS WERE INSERTED. PATIENT WAS PRESCRIBED 45 DAY OF ANTIBIOTICS. PATIENT HAS NO KNOWN ALLERGIES, NON-SMOKER AND NOT DIABETIC. PATIENT IS FINE TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162292 BIO-COMP INTERF SCREW CANN DELTA TAP 11 X 35MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 297094

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AR-1926BC, BIO-COMP. PUSHLOCK, LOT #375910.| AR-1588T, ACL TIGHTROPE, LOT 381685