BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ MED LFT FOSSA COMP

    MDR report key: 2802397 · Received October 24, 2012

    Report

    Report Number
    0001032347-2012-00142
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    March 6, 2008
    Report Date
    October 4, 2012
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK IN ORIGINAL MDR REPORT AS DATE OF REVISION SURGERY WAS ESTIMATED (B)(6)2007 BY PATIENT. CLINICAL RESEARCH MANAGER, (B)(4), RECEIVED INFORMATION FROM OPERATING SURGEON, DR.(B)(6), WITH THE CORRECT DATE OF (B)(6) 2008.

    Additional Manufacturer Narrative · 1

    OPERATIVE REPORT RECEIVED FROM SURGEON TO THE CLINICAL RESEARCH DEPARTMENT INDICAING THE PATIENT DID HAVE A REVISION TO REPOSITION THE IMPLANT; HOWEVER, NO IMPLANT WAS REMOVED. THIS IMPLANT REMAINS IN THE PATIENT. THE ORIGINAL REPORT THAT THE IMPLANT WAS REMOVED FROM THE PATIENT WAS INCORRECT.

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVAUATION IS ABLE TO BE CONDUCTED. 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

    PATIENT REPORTED PAIN AND SWELLING DURING TMJ SURVEY. LEFT IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ MED LFT FOSSA COMP TMJ LZD BIOMET MICROFIXATION N/A 148970

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization