BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT MATCHED TMJ

    MDR report key: 3901475 · Received June 30, 2014

    Report

    Report Number
    0001032347-2014-00195
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED TMJ MANDIBLE WAS EVALUATED FOR THE COMPLAINT OF NOT FITTING THE PATIENT. THE MANDIBLE WAS FOUND TO FIT THE RETURNED MODEL WITH NO ISSUES AND THERE WAS NO SIGN OF DAMAGE. WITH THE INFORMATION PROVIDED, THE COMPLAINT COULD NOT BE SUBSTANTIATED AND THE MOST LIKELY UNDERLYING CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE PRODUCT RETURN HAS BEEN REQUESTED BUT NOT YET RECEIVED OR EVALUATED BY THE MANUFACTURER. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    SURGEON REPORTS THE CUSTOM TMJ IMPLANT DID NOT FIT CORRECTLY DURING SURGERY AND THE SURGERY WAS DELAYED OVER ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380132 PATIENT MATCHED TMJ TMJ LZD BIOMET MICROFIXATION N/A 540770A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization