BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - SMART TOE

    MDR report key: 2562739 · Received May 2, 2012

    Report

    Report Number
    8031020-2012-00113
    Event Type
    Injury
    Date Received
    May 2, 2012
    Date of Event
    April 18, 2012
    Report Date
    April 18, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    KWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE DEVICES ARE NOT AVAILABLE DUE TO THE ONGOING LITIGATION.

    Description of Event or Problem · 1

    THE PT REPORTED, I HAD THE THREE IMPLANTS PLACED IN EARLY (B)(6) 2011. THE ANGLED ONE BROKE ON (B)(6) 2012 WHEN I STUBBED MY TOE ON THE CORNER OF A COUCH. I HAD IT X-RAYED AT THAT TIME. WE FOUND A HAIRLINE FRACTURE IN MY PINKY TOE AND NO BREAK IN THE 4TH TOE ITSELF BUT THE IMPLANT PRONGS HAD BROKEN. I DIDN'T EVEN REALIZE I HAD STUBBED THE 4TH TOE AS UNFORTUNATELY THE PINKY TOOK MOST OF THE IMPACT. WE DECIDED TO MONITOR THE BROKEN IMPLANT. AFTER A MONITORING X-RAY ON (B)(6), THE SURGEONS WERE CONCERNED THAT IT HAS CONTINUED TO MOVE AND IS NOW ANGULATED. WE ALSO NOTICED ON TUESDAY (B)(6) THAT THE IMPLANT IS BROKEN IN MY SECOND TOE (WASN'T SEEN ON THE FIRST X-RAY). MIND YOU I'VE BEEN LIMITED TO NO PHYSICAL THERAPY, RUNNING, ETC. WALKING ONLY. I FLEW TO THE (B)(6) CLINIC IN (B)(6), TUESDAY, (B)(6) TO BE EVALUATED AS THE TOE WAS STILL VERY SWOLLEN AND SORE 6 WEEKS OR SO OUT. ON (B)(6) I HAD SURGERY TO REMOVE THE BROKEN IMPLANT IN MY 4TH TOE. THEY ALSO TOOK A BONE GRAFT FROM MY HEEL AND PLACED A NEW SMART TOE IMPLANT IN THE 4TH TOE. THE SECOND TOE THEY DECIDED TO LEAVE AS IS SINCE THE TOE IS STILL ALIGNED AND IT'S DIFFICULT AND PAINFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - SMART TOE IMPLANT KWH STRYKER OSTEOSYNTHESIS SELZACH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention