BEUDAMED
    FDA Adverse Event Other Summary report: N

    MTP CP FUSION, RIGHT PLATE

    MDR report key: 5741197 · Received June 17, 2016

    Report

    Report Number
    MW5062947
    Event Type
    Other
    Date Received
    June 17, 2016
    Date of Event
    August 5, 2015
    Report Date
    June 17, 2016
    Manufacturer
    STRYKER
    Product Code
    HRS
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD SURGERY, ARTHRODESIS AND FUSION SINGLE JOINT RIGHT TOE (1ST MTP FUSION). ALSO HAD EXCISION OF NEUROMA 2ND INNERSPACE RIGHT FOOT AT THE SAME TIME. THE FUSION NEVER HAPPENED, JUST HAD 2ND SURGERY WITH BONE GRAFT. SECOND SURGEON FOUND THE ORIGINAL PLATE BROKEN AND THE SCREWS LOOSE; WAS SENT TO PATHOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386338 MTP CP FUSION, RIGHT PLATE MTP CP FUSION, RIGHT PLATE HRS STRYKER PLP14342 (PLATE) 1436512
    386339 SCREWS BN ANCHORAGE-3MM 14MM SCREWS BN ANCHORAGE-3MM 14MM HWC PLSL3014 1436512
    386340 SCREWS BN ANCHORAGE-3MM 14MM SCREWS BN ANCHORAGE-3MM 14MM HWC PLSL3014 1436512
    386341 BN 3MM 16MM ANCHORAGE BN 3MM 16MM ANCHORAGE LXH PLSL3016 1436512
    386342 BN 3MM 16MM ANCHORAGE BN 3MM 16MM ANCHORAGE LXH PLSL3016 1436512
    386343 BN 33 26MM BN 33 26MM LXH PLSS 3026 1436512

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR