BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAOSSEOUS FIXATION SYSTEM

    MDR report key: 3181421 · Received June 14, 2013

    Report

    Report Number
    3005039508-2013-00009
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    September 1, 2012
    Report Date
    June 7, 2013
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Product Code
    HTY
    PMA / PMN Number
    K120165
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADD'L ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE IMPLANT WAS REQUESTED FOR EVAL BUT WAS REPORTED AS DISCARDED BY THE FACILITY. NO OTHER SIMILAR COMPLAINTS OF IMPLANT COMPLETELY DISLODGING WHERE FOUND. MFG RECORDS WERE RE-REVIEWED. IFS IMPLANTS PASSED ALL RELEASE REQUIREMENTS PRIOR TO DISTRIBUTION. EVAL OF AN X-RAY IMAGE SHOWS A DISLODGED IFS IMPLANT WHERE THE HALLUX IS PRESSING THE TOES LATERALLY. PER THE REP, PRESENT DURING THE CASE IMPROPER SURGICAL TECHNIQUE LIKELY CONTRIBUTED TO THE EVENT. THE PROXIMAL END OF THE IMPLANT WAS NOT PROPERLY REDUCED. IMPROPER ENGAGEMENT OF THE BARS ON THE PROXIMAL PART OF THE IMPLANT CAUSED THE IMPLANT TO DISLODGE.

    Description of Event or Problem · 1

    ON OR ABOUT (B)(6) 2012, THE PT UNDERWENT FOOT SURGERY, USING AN IFS IMPLANT FOR HAMMERTOE. THE PT RETURNED TO THE PHYSICIAN FIVE WEEKS POST OP. AT THIS VISIT, X-RAYS WERE TAKEN AND REVEALED THAT THE DEVICE WAS DISLODGED. A REVISION SURGERY USING A CANNULATED SCREW WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271434 INTRAOSSEOUS FIXATION SYSTEM PIN, FIXATION, SMOOTH HTY ORTHOHELIX SURGICAL DESIGNS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention