BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-TENODESIS SCREW

    MDR report key: 2854732 · Received December 3, 2012

    Report

    Report Number
    1220246-2012-00243
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    February 1, 2011
    Report Date
    November 5, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 NOT AVAILABLE FOR EVALUATION THEREFORE THE EVENT AS PUBLISHED IN THE LITERATURE REVIEW SOURCE COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. THIS REPORT IS PROVIDED BASED ON A LITERATURE REVIEW. 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A WHITE PAPER PUBLICATION OF 2011 THAT THERE WAS ONE PATIENT WHO AT 6 WEEKS POST-OP, HAD A FOREIGN BODY REACTION, PAINFUL SINUS DISCHARGE AND INFLAMMATORY SYMPTOMS AND UNDERWENT DEBRIDEMENT AND SCREW REMOVAL. CULTURE WAS NEGATIVE FOR PROPIONIBACTERIUN ACNES.THE PATIENT'S INFLAMMATORY SYMPTOMS WAS RESOLVED AFTER REMOVAL OF THE SCREW AND BONY REGROWTH WAS SEEN 9 MONTHS POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-TENODESIS SCREW SCREW, FIXATION, BONE HWC ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other