BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-CORKSCREW FT, 5.5MM

    MDR report key: 1259329 · Received December 9, 2008

    Report

    Report Number
    1220246-2008-00249
    Event Type
    Injury
    Date Received
    December 9, 2008
    Date of Event
    October 16, 2008
    Manufacturer
    ARTHREX, INC
    Product Code
    HWC
    PMA / PMN Number
    K061863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE REQUESTED FOR EVALUATION BUT WERE NOT RETURNED, THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE SURGEON REPORTED HAVING EXPLANTED ONE BIO-CORKSCREW FT, 5.5MM, AR-1927BF, LOT 166210 AND TWO PUSHLOCKS, PEEK, 4.5MM X 18.5MM, LOT 161371 AND 166927. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFO AVAILABLE AND WITHOUT DEVICE EVALUATION. DEVICE HISTORY RECORDS REVIEW REVEALED NOTHING RELEVANT TO THIS EVENT. BASED ON THE INFO PROVIDED, THIS ISSUE IS MOST LIKELY RELATED TO AN ADVERSE REACTION OF THE PT TO THE MATERIAL(S) IMPLANTED. PRODUCT DFU WARNS OF A POSSIBLE ALLERGIC REACTION TO THE IMPLANT MATERIALS. PT SENSITIVITY SHOULD ALWAYS BE CONSIDERED/ RULED OUT PRIOR TO THE PROCEDURE. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR ANY/ALL OF THESE PART/LOT COMBINATIONS. THE POTENTIAL CAUSES OF THIS EVENT ARE BEING COMMUNICATED TO THE EVENT REPORTER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT HAD A REACTION TO BIO-IMPLANTS. THE PT DID WELL FOR ONE MONTH POST-OP, AND THEN STARTED DETERIORATING. ALL CULTURES WERE NEGATIVE; SEPTIC ARTHRITIS WAS RULED OUT. WHITE CELL COUNT WAS NOT SIGNIFICANTLY ELEVATED. NO LACTOSE INTOLERANCE. A SECOND SURGERY WAS PERFORMED TO EXPLANT THE DEVICES. PT SYMPTOMS IMPROVED/RESOLVED. DATE OF ORIGINAL SURGERY (IMPLANTATION) WAS 2008 AND DATE OF SECOND SURGERY (EXPLANTATION) WAS APPROX TWO MONTHS LATER. FOLLOW-UP WITH THE REPORTER PROVIDED INFO THAT THE PT "SMOULDERED ALONG" AFTER HIS INITIAL SURGERY WITH GENERAL/VAGUE SYMPTOMS OF INFECTION AND NOT FEELING WELL. UPON EXPLANT SURGERY, THE IMPLANTS WERE GROSSLY LOOSE WITH SIGNIFICANT OSTEOLYSIS SURROUNDING THEM. THE SURGEON SWITCHED TO ALL PEEK IMPLANTS INSTEAD. THE PT IS CURRENTLY DOING BETTER. NO FURTHER PT INFO 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-CORKSCREW FT, 5.5MM HWC ARTHREX, INC NA 166210

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention LOT 161371 & 166927| 4.5MM X 18.5 MM| PEEK| AR-1922PS| PUSHLOCK