BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOMPOSITE INTERFERENCE SCREW W/ DISP. SHEATH

    MDR report key: 4884069 · Received July 1, 2015

    Report

    Report Number
    1220246-2015-00175
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 11, 2015
    Manufacturer
    ARTHREX, INC.
    Product Code
    MAI
    PMA / PMN Number
    K071176
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (DATE OF BIRTH) 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 RECEIVED AND AN EVALUATION WAS CONDUCTED. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. RETURNED DEVICE INCLUDE ONE BIO-COMPOSITE INTERFERENCE SCREW. SCREW APPEARS TO HAVE STARTED THE DEGRADATION PROCESS. BASED ON THE INFORMATION PROVIDED AND DEVICE EVALUATION, THE MOST LIKELY CAUSE(S) OF THIS EVENT IS AN ADVERSE REACTION OF THE PATIENT TO THE MATERIAL(S) IMPLANTED. PRODUCT DIRECTIONS FOR USE PROVIDED WITH THE DEVICE WARNS OF POSSIBLE FOREIGN BODY AND ALLERGIC-LIKE REACTIONS TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY TO DEVICE MATERIALS MUST BE CONSIDERED PRIOR TO IMPLANTATION. 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 THE PATIENT HAD AN ACL RECONSTRUCTION ON (B)(6) 2015. TWO MONTHS POST-OP, THE PATIENT HAD SKIN BREAKDOWN ON TIBIA OVER THE WOUND WITH DRAINAGE. AN MRI SHOWED TIBIAL EDEMA AND SUB-Q INFLAMMATION. ON (B)(6) 2015, A KNEE SCOPE PROCEDURE WAS PERFORMED AND THE SURGEON USED THE ORIGINAL INCISION SIGHT AND REMOVED THE SCREW, CLEANED OUT THE WOUND AND PACKED IT WITH A BONE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428401 BIOCOMPOSITE INTERFERENCE SCREW W/ DISP. SHEATH FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other