BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEK TENODESIS SCREW, 6.25MM X 15MM

    MDR report key: 2103283 · Received May 26, 2011

    Report

    Report Number
    1220246-2011-00084
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    February 1, 2011
    Report Date
    May 4, 2011
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, 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 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 FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DISCARDED BY FACILITY.

    Description of Event or Problem · 1

    PATIENT WAS HAVING PAIN AT INSERTION SITE WITH A PUS DISCHARGE, (B)(6) AFTER SURGERY. THE PATIENT HAD DEVELOPED A CYST AROUND THE WOUND, WAS FLUSHED AND CLEANED AND REDRESSED. THE PATIENT WAS TOLD TO SEE WHAT HAPPENS WITHIN THE NEXT COUPLE DAYS. PATIENT RETURNED NOT FEELING ANY BETTER AND IMPLANT WAS REMOVED. THE TENDON WAS ALREADY REATTACHED TO THE BONE, NO ADDITIONAL IMPLANTS WERE NEEDED. WOUND WAS REFLUSHED AND REDRESSED. PATIENT IS DOING WELL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEEK TENODESIS SCREW, 6.25MM X 15MM SCREW, FIXATION, BONE HWC ARTHREX, INC. 177956

    Patients

    Seq Age Sex Outcome Treatment
    1 Other