BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXOTOE STAPLE

    MDR report key: 15321074 · Received August 30, 2022

    Report

    Report Number
    3015200653-2022-00001
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    April 28, 2021
    Report Date
    August 30, 2022
    Manufacturer
    EXOTOE, LLC
    Product Code
    JDR
    PMA / PMN Number
    K172205
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED AND NO ISSUES WERE IDENTIFIED. DR. (B)(6) STATED WHEN THE INCISION DEHISCED, THE PATIENT WAS PLACED ON ANTIBIOTICS AND DUE TO THE SIZE OF THE IMPLANT AND WITHOUT SOFT TISSUE COVERAGE, DR. (B)(6) EXPLANTED THE EXOTOE IMPLANT AND GRAFTED THE SKIN TO HEAL. DR. (B)(6) BELIEVES THE HARDWARE WAS RIGHT UNDERNEATH THE SKIN AND THERE WAS PROBABLY POOR TENDON COVERAGE OVER THE IMPLANT WHICH LED TO DIRECT DEHISCENCE. ANOTHER REASON HE STATED WOULD BE THAT THIS IMPLANT REQUIRES A SIGNIFICANT INCREASED AMOUNT OF DISSECTION COMPARED TO MOST HAMMERTOE PROCEDURES AND THAT THE SKIN WAS STRETCHED TOO MUCH.

    Description of Event or Problem · 0

    INCISIONAL DEHISCENCE WITH ULTIMATELY EXPLANT OF THE DEVICE DUE TO HARDWARE EXPOSURE ON THE RIGHT SECOND TOE. DR. (B)(6) STATED THE K-WIRE WAS REMOVED AT TWO WEEKS AND ABOUT 3 DAYS AFTER IT WAS REMOVED, THE INCISION DEHISCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299828 EXOTOE STAPLE STAPLE, FIXATION, BONE JDR EXOTOE, LLC 276109319A

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention K-WIRE USED FOR TEMPORARY FIXATION