BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM MIDFOOT FUSION BOLT 105MM

    MDR report key: 3090389 · Received May 2, 2013

    Report

    Report Number
    8030965-2013-02101
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K081071
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE REPORTABLE WILL NOT BE RETURNED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. RETRACT EVENT DATE: EXACT DATE UNKNOWN. RETRACT EXPLANT DATE: ENTIRE BOLT WAS NOT REMOVED.

    Description of Event or Problem · 1

    A REPORT FROM SYNTHES (B)(6) INDICATED: PATIENT WAS IMPLANTED ON (B)(6) 2012, WITH 6.5MM MIDFOOT FUSION BOLT SCREW ON THE METATARSAL. EXAM ON AN UNKNOWN DATE REVEALED THE BOLT WAS BROKEN. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013. THE SURGEON WAS ABLE TO RETRIEVE HALF OF THE BOLT, BUT THE OTHER HALF REMAINS IMPLANTED IN THE PATIENT. SURGEON REVISED WITH ANOTHER COMPANY'S PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191825 6.5MM MIDFOOT FUSION BOLT 105MM HWC SYNTHES GMBH 3134558

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention