BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST0AII 20 - SMART TOE IM

    MDR report key: 2844920 · Received October 23, 2012

    Report

    Report Number
    8031020-2012-00257
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HTY
    PMA / PMN Number
    K112197
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    SALES REP REPORTED ON BEHALF OF THE CUSTOMER THE FOLLOWING: THE PRODUCT WAS OPENED FROM STERILE PACKAGING AND IT WAS NOTED THAT THE IMPLANT WAS BENT. UPON LOOKING AT THIS, THERE IS A SLIGHT BENDING ON THE EYE OF THE IMPLANT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST0AII 20 - SMART TOE IM IMPLANT HTY STRYKER OSTEOSYNTHESIS SELZACH NA F000182-R03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other