BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPOROMANDIBULAR JOINT SMALL LEFT FOSSA COMPONENT

    MDR report key: 3070823 · Received April 22, 2013

    Report

    Report Number
    0001032347-2013-00112
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    April 1, 2010
    Report Date
    May 7, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO THE STUDY: NO FAILURE MODE WAS IDENTIFIED. ADDITIONALLY, THE CLINICAL EVIDENCE SUPPORTS THAT THE REVISION SURGERY WAS THE RESULT OF A BIOLOGICAL RESPONSE (INFECTION). SEROUS PUS, INFLAMMATION, AND GRANULATION TISSUE WERE ALL NOTED DURING THE REVISION SURGERY. CT IMAGING NOTING FLUID COLLECTION ALSO SUPPORTS INFECTION AS ETIOLOGY. THE CONFIRMATION OF A MODIFIED FOSSA FLANGE SUPPORTS A PROBABLE RELATIONSHIP BETWEEN DEVICE MODIFICATION AND A SUBSEQUENT INFECTION.

    Description of Event or Problem · 1

    THE FOSSA WAS EXPLANTED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171349 TEMPOROMANDIBULAR JOINT SMALL LEFT FOSSA COMPONENT FOSSA IMPLANT LZD BIOMET MICROFIXATION N/A 122790B

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R