BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    45MM LEFT STANDARD MANDIBULAR

    MDR report key: 1649044 · Received April 2, 2010

    Report

    Report Number
    1032347-2010-00033
    Event Type
    Malfunction
    Date Received
    April 2, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 8, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING OUR INVESTIGATION, WE FOUND WHERE 24-6546 MANUFACTURING LOT 082800 WAS MIXED WITH 24-6646 MANUFACTURING LOT 080300. WE WILL BE ISSUING A FIELD ACTION TO HAVE THESE DEVICES RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, THE SURGEON SELECTED TO USE A 45MM LEFT STANDARD MANDIBULAR IMPLANT FOR A PATIENT, HOWEVER, THE IMPLANT THAT WAS ETCHED AND LABELED AS THE 45MM LEFT STANDARD MANDIBULAR WAS ACTUALLY A 45MM LEFT STANDARD OFFSET MANDIBULAR, AND COULD NOT BE USED FOR THIS PATIENT, RESULTING IN A SLIGHT DELAY IN THE SURGERY. THE SURGEON WAS ABLE TO USE A 45MM LEFT NARROW MANDIBULAR FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 45MM LEFT STANDARD MANDIBULAR TMJ LZD BIOMET MICROFIXATION 082800A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization