BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOMP. INTERFERENCE SCREW, FULL THREAD

    MDR report key: 3890025 · Received June 24, 2014

    Report

    Report Number
    1220246-2014-00100
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 28, 2012
    Report Date
    June 3, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K071176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 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. BASED ON THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE(S) OF THIS 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. 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 INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. CUSTOMER WILL NOT RETURN THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAD A PATIENT WITH PRIOR ACL RECONSTRUCTION DESCRIBING PAIN ON THE TIBIA BY THE TUNNEL AND SCREW SITE. HE BROUGHT THE PATIENT IN ON (B)(6) 2014 FOR A FOLLOW UP SURGERY. WHEN HE SCOPED THE KNEE THE ACL WAS INTACT BUT WHEN HE INCISED THE TUNNEL SITE "WHITE-LIKE" CLUMPS AND PUSS LEAKED OUT OF THE TUNNEL. HE SAID HE COULD SEE AN EMPTY CAVITY WHERE HE NOTICED THREADS IN THE TUNNEL WHERE IT APPEARED THE SCREW WOULD BE. THE INITIAL SURGERY WAS ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369183 BIOCOMP. INTERFERENCE SCREW, FULL THREAD FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. 461449

    Patients

    Seq Age Sex Outcome Treatment
    1 Other