BEUDAMED
    FDA Adverse Event Injury Summary report: N

    45 MM RIGHT STANDARD MANDIBLE

    MDR report key: 3994209 · Received August 8, 2014

    Report

    Report Number
    0001032347-2014-00233
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 17, 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
    OR, US
    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: THE MODE OF FAILURE WAS IDENTIFIED AS "ENVIRONMENTAL CRACKING." THE CAUSE OF FAILURE WAS DETERMINED TO BE "BIOLOGICAL." CONCERNING THE MODE OF FAILURE, THE STUDY STATES THAT SIGNS OF CRACKING OBSERVED ON THE FOSSA COMPONENT CANNOT BE COMPLETELY RULED OUT AS A CONSEQUENCE OF COMBINED EFFECTS OF MECHANICAL STRESS (BONE GROWTH IN A REDUCED SPACE) AND A REACTION WITH THE ENVIRONMENT. SINCE THE WEAR SIGNS IN THE ARTICULAR SURFACE AFTER 12 YEARS OF NORMAL FUNCTIONING, DO NOT MATCH THE MATERIAL DAMAGE IN THE SAME COMPONENT (PRESUMABLY FROM RETRIEVAL MANEUVERS) IT IS POSSIBLE THAT OBSERVED CRACKS WERE ALSO A RESULT OF THE EXPLANT PROCEDURE. POST EXPLANT OXIDATION AND CRACKING OF THE MATERIAL DUE TO ENVIRONMENTAL EXPOSURE CANNOT BE RULED OUT EITHER. CONCERNING THE CAUSE OF FAILURE, THE STUDY STATES THAT HETEROTOPIC BONE FORMATION WAS SUSPECTED BY A PRE EXPLANT CT AND CONFIRMED DURING THE REVISION SURGERY. THIS IS SUPPLEMENTAL REPORT 2 OF 4 FOR THE SAME EVENT. SUPPLEMENTAL REPORTS 1, 3, & 4 ARE REPORTED ON MFR #0001032347-2014-00232-1, 0001032347-2014-00234-1 & 0001032347-2014-00235-1.

    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. PAIN IS A PERCEPTION BY THE PATIENT AND THE CAUSE OF PAIN CANNOT BE DETERMINED TO BE A RESULT OF THE IMPLANT'S FORM, FIT, OR FUNCTION. 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. FILE 2 OF 6

    Description of Event or Problem · 1

    A REVISION SURGERY DUE TO PAIN WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467820 45 MM RIGHT STANDARD MANDIBLE TMJ MANDIBLE LZD BIOMET MICROFIXATION N/A 768620

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R