BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPOROMANDIBULAR JOINT MEDIUM RIGHT FOSSA COMPONENT

    MDR report key: 3070875 · Received April 22, 2013

    Report

    Report Number
    0001032347-2013-00115
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 29, 2010
    Report Date
    June 9, 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
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND ANALYZED AS PART OF THE (B)(6) STUDY. THIS SUPPLEMENTAL REPORT IS LATE INFORMATION RECEIVED FROM THE (B)(6) STUDY, WHICH WAS REPORTED AS EXPECTED TO THE PS STUDIES PROGRAM, BUT INADVERTENTLY NOT RECOGNIZED AS 803 REPORTABLE UNTIL AFTER THE CLOSE OF THE STUDY. ACCORDING TO THE STUDY: NO FAILURE MODE WAS IDENTIFIED. ADDITIONALLY, EVIDENCE WAS FOUND OF OSTEOLYSIS AT THE INSERTION SITE OF THE SCREWS IN THE MANDIBULAR COMPONENT, CAUSING THE LOOSENING OF THE SCREWS AND EVENTUAL EXPLANTATION. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. REPORT 1 OF 2 IS REPORTED ON MFR #1032347-2010-00041-1.

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A KNOWN LOT NUMBER, REVIEW OF THE MANUFACTURING RECORDS CANNOT BE PERFORMED. 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

    THE RIGHT FOSSA WAS REMOVED DUE TO SCREWS LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171551 TEMPOROMANDIBULAR JOINT MEDIUM RIGHT FOSSA COMPONENT FOSSA IMPLANT LZD BIOMET MICROFIXATION N/A 660740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R