BEUDAMED
    FDA Adverse Event Injury Summary report: N

    45MM LEFT STANDARD MANDIBLE

    MDR report key: 5676997 · Received May 24, 2016

    Report

    Report Number
    0001032347-2016-00237
    Event Type
    Injury
    Date Received
    May 24, 2016
    Date of Event
    January 13, 2016
    Report Date
    September 26, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS IDENTIFIED ON JULY 21, 2016 DUE TO AN INADVERTENT ERROR, THE DEVICE INFORMATION SUBMITTED IN THIS REPORT WAS A DUPLICATE OF THE DEVICE INFORMATION IN REPORT 0001032347-2016-00235. CORRECTED FROM SMALL LEFT FOSSA COMPONENT TO 45MM LEFT STANDARD MANDIBLE. CORRECTED FROM FOSSA IMPLANT TO MANDIBLE. CATALOG NUMBER WAS CORRECTED FROM 24-6563 TO 24-6545. LOT NUMBER WAS CORRECTED FROM 509610B TO 509410B. EXPIRATION DATE WAS CORRECTED FROM 12/31/2018 TO 5/1/2019. UNIQUE IDENTIFIER (UDI) # WAS CORRECTED FROM (B)(4). DEVICE MANUFACTURE DATE WAS CORRECTED FROM 1/1/2014 TO 2/14/2014.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2016-00235-1, 0001032347-2016-00236-1, 0001032347-2016-00238-1, 0001032347-2016-00239-1, 0001032347-2016-00240-1, AND 0001032347-2016-00241-1.

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THE DEVICE HISTORY RECORDS SHOW THAT THE LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. 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. THIS IS REPORT 3 OF 7 FOR THE SAME EVENT. REPORTS 1 & 2, AND 4 THROUGH 7 ARE REPORTED ON MFR #0001032347-2016-00235 THROUGH 0001032347-2016-00236 AND 0001032347-2016-00238 THROUGH 0001032347-2016-00241.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT THAT THE JOINTS WERE PLACED INCORRECTLY DURING SURGERY ON ONE SIDE, BEYOND THE SOCKET AREA. THE REVISED TMJ IMPLANTS WERE REPLACED WITH CUSTOM JOINTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BILATERAL REVISION OCCURRED AS A RESULT OF THE IMPLANTS DISLOCATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330632 45MM LEFT STANDARD MANDIBLE MANDIBLE LZD BIOMET MICROFIXATION N/A 509410B

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R