BEUDAMED
    FDA Adverse Event Other Summary report: N

    CORKSCREW FT II, 5.5 MM X 16 MM W/TWO #2 FIBERWIRE

    MDR report key: 1200205 · Received October 6, 2008

    Report

    Report Number
    1220246-2008-00205
    Event Type
    Other
    Date Received
    October 6, 2008
    Date of Event
    January 1, 2008
    Report Date
    September 8, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K061863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS STILL IMPLANTED AND COULD NOT BE RETURNED FOR EVALUATION. 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. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION. REVIEW OF COMPLAINT RECORDS FOR ANY SIMILAR EVENTS WITH SIMILAR ARTHREX DEVICES (TITANIUM IMPLANTS) ALSO PRODUCED NO RESULTS. THE CONDITION REPORTED COULD BE RELATED TO AN ADVERSE PATIENT REACTION TO ANY OF THE MATERIALS IMPLANTED. PRODUCT DFU WARNS OF A POSSIBLE ALLERGIC REACTION TO THE IMPLANT MATERIALS. PATIENT SENSITIVITY MUST ALWAYS BE CONSIDERED PRIOR TO IMPLANTATION. THE CAUSE OF THE COMPLAINANT'S EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE. THE POTENTIAL CASES OF THIS EVENT HAVE BEEN COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT IS HAVING A POSSIBLE REACTION TO AN IMPLANT. THE PATIENT REPORTED HAVING HAD A ROTATOR CUFF SURGERY TWO YEARS AGO (2006). SHE STATED TWO CORKSCREW ANCHORS WERE IMPLANTED. SHE REPORTS HER SHOULDER NOW IS RED, (AN AREA ABOUT THE SIZE OF A HAND) AND IS STREAKED. SHE STATED SHE HAS SEEN SEVERAL DOCTORS INCLUDING AT LEAST TWO DERMATOLOGISTS. WITHIN THE PAST TWO WEEKS SHE HAD A FEVER AND WAS TREATED WITH ANTIBIOTICS. THE PATIENT STATED SHE IS ONLY LOOKING FOR INFORMATION AS TO THE POSSIBLE CAUSE OF HER SYMPTOMS. FOLLOW-UP WITH THE REPORTER PROVIDED INFORMATION THAT THE PATIENT IS CONTINUING TO SEEK MEDICAL CARE TO DETERMINE THE CAUSE OF HER SYMPTOMS. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR IN FOLLOW-UP COMMUNICATIONS. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORKSCREW FT II, 5.5 MM X 16 MM W/TWO #2 FIBERWIRE HWC ARTHREX, INC. NA 92586

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other