BEUDAMED
    FDA Adverse Event Summary report: N

    MAND.INFANT LRG DISTRACTOR

    MDR report key: 1915129 · Received December 6, 2010

    Report

    Report Number
    1032347-2010-00196
    Date Received
    December 6, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    K030425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DISCOVERED AFTER THE SURGERY, THE PLATES AND SCREWS BEING USED WERE NOT COMPATIBLE TOGETHER. THE SCREWS WERE NON LOCKING AND THE PLATES WERE LOCKING. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DOCTOR WAS TRYING TO IMPLANT A MANDIBULAR DISTRACTION DEVICE, AND DUE TO THE FACT THE PLATES AND SCREWS WERE NON-COMPATIBLE, THE SURGERY WAS DELAYED 3-4 HOURS WHILE THE DOCTOR ATTEMPTED SEVERAL DIFFERENT PLATE AND SCREW COMBINATIONS. IT WAS DETERMINED AFTER THE SURGERY THE DRIVE SCREWS THE DOCTOR WAS TRYING TO USE WERE NON-LOCKING SCREWS, AND THE PLATES HE WAS TRYING TO PUT THEM IN WERE LOCKING, THEREFORE THEY WERE NON-COMPATIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAND.INFANT LRG DISTRACTOR DISTRACTON DEVICE JEY BIOMET MICROFIXATION 077180

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization