BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE ATRA GRASPERSGL

    MDR report key: 1031599 · Received March 8, 2008

    Report

    Report Number
    2916714-2007-00025
    Event Type
    Injury
    Date Received
    March 8, 2008
    Date of Event
    August 1, 2007
    Report Date
    September 13, 2007
    Manufacturer
    SMITH & NEPHEW
    Product Code
    MDM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT BROKE INSIDE THE PATIENT, DURING SURGERY, AT THE JAW. PART OF THE JAW WAS IMMEDIATELY RETRIEVED; HOWEVER, IT WAS NOTED THEY WERE MISSING A PIECE OF JAW. X-RAY'S WERE TAKEN, LOCATED PIECE AND RETRIEVAL WAS ATTEMPTED. UNABLE TO RETRIEVE, DID FLUOROSCOPY AND ATTEMPTED RETRIEVAL AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE ATRA GRASPERSGL NONE MDM SMITH & NEPHEW 8360-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other