BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIO-TENODESIS SCREW 6.5 MM X 15 MM

    MDR report key: 1338648 · Received December 22, 2008

    Report

    Report Number
    1220246-2008-00259
    Event Type
    Other
    Date Received
    December 22, 2008
    Date of Event
    September 3, 2008
    Report Date
    November 27, 2008
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    PMA / PMN Number
    K051726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE BEEN RECEIVED AND THE EVALUATION IS IN PROCESS. DEVICE HISTORY RECORD REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. THIS DEVICE IS SOLD STERILE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/LOT COMBINATION; NO REPORTS OF SEPTICEMIA OR INFECTION HAVE BEEN REPORTED FOR THIS PART FROM ANY LOT. PATIENT FACTORS AND MEDICAL HISTORY THAT COULD NEGATIVELY AFFECT IMMUNE STATUS (SUCH AS SMOKING, ALCOHOL CONSUMPTION, DRUG USE, POOR CIRCULATION, POOR NUTRITION, ETC.) WERE REQUESTED BUT NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE POST-OPERATIVE SEPTICAEMIA COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFO IS OBTAINED FROM THE DEVICE EVAL, A FOLLOW UP REPORT WILL BE SUBMITTED. THE RESULTS OF THIS INVESTIGATION ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO SCREWS WERE FULLY REMOVED AFTER A PERIOD OF THERE MONTHS BECAUSE THE PATIENT HAD CONTRACTED SEPTICAEMIA. IN ADDITION, A COMPOSITE SCREW THAT WAS NOT AN ARTHREX, INC. PRODUCT WAS ALSO REMOVED FROM THE PATIENT AT THE SAME TIME. THE PATIENT'S SYMPTOMS WERE DESCRIBED AS ANKLE INFLAMMATION, YELLOWISH FLOW WITH SCAR DISUNITY. FOLLOW-UP COMMUNICATION AFTER THE INITIAL REPORT REVEALED THE PATIENT IS DOING WELL. THE SURGEON WOULD NOT PROVIDE ADDITIONAL INFORMATION AS REQUESTED REGARDING THE BACTERIA IDENTIFIED FROM THE INFECTION, PATIENT HISTORY, OR ANY FURTHER INFORMATION AS TO THE POSSIBLE ROOT CAUSE OF THE INFECTION. HE NOW REPORTED THE ARTHREX SCREWS AS NOT RESPONSIBLE FOR THE EVENT. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR IN RESPONSE TO FOLLOW-UP COMMUNICATION. 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 BIO-TENODESIS SCREW 6.5 MM X 15 MM HWC ARTHREX, INC. NA 141966

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other| R INFORMATION REQUESTED BUT NOT PROVIDED