BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMOID NOTCH

    MDR report key: 859071 · Received June 1, 2007

    Report

    Report Number
    3003640913-2007-00004
    Event Type
    Other
    Date Received
    June 1, 2007
    Date of Event
    April 11, 2007
    Report Date
    May 29, 2007
    Manufacturer
    SMALL BONE INNOVATION
    Product Code
    KWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SURGEON NOTED THAT THE SIGMOID NOTCH COMPONENT PLACEMENT WAS NOT IDEAL DUE TO SOMEWHAT ABNORMAL ANATOMY OF THE ULNA SHAFT. DORSAL DISLOCATION OF THE ULNA AND DISLODGING OF THE POLY INSERT FROM THE SIGMOID NOTCH PLATE REQUIRED REVISION SURGERY. A NEW POLY PIECE WAS SNAPPED ONTO THE SIGMOID NOTCH PLATE. CARE WAS TAKEN TO INSURE NO SOFT TISSUE BECAME LODGED BETWEEN THE POLY PIECE AND THE PLATED. SOFT TISSUE WAS ATTACHED TO THE ULNAR HEAD IMPLANT'S SUTURE HOLES TO FURTHER STABILIZE THE JOINT.

    Description of Event or Problem · 1

    OSTEOARTHRITIS PT DISLOCATED THEIR ULNA DORSALLY AFTER IMPLANT SURGERY. POLY INSERT BECAME DISLODGED FROM THE SIGMOID NOTCH PLATE. REVISION SURGERY WAS REQUIRED TO REPLACE THE POLY INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMOID NOTCH WRIST JOINT ULNAR (HEMI-WRIST) POLYMER KWN SMALL BONE INNOVATION 390-0315 38209001

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other