BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM

    MDR report key: 3973502 · Received August 1, 2014

    Report

    Report Number
    0001032347-2014-00231
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 8, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK910038
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE LOT HISTORY OF THE IMPLANTED UNIT IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION 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. FILE FOUR OF FOUR FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THE TMJ COORDINATOR RECEIVED TMJ TRACKING CARDS INDICATING A REVISION SURGERY WAS CONDUCTED DUE TO FAILED HARDWARE AND JAW PAIN. UPON FOLLOW UP WITH THE DISTRIBUTOR ASSOCIATE, HE REPORTED THERE WAS CONCERN THAT THE FOSSA IMPLANT WAS A BIT POSTERIOR AND WITH THE NEW IMPLANTS, THERE WAS RELOCATION AS WELL AS A CHANGE IN SIZE FROM THE EXPLANTED ONE. HE ALSO REPORTED THE FACILITY DISCARDED THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450887 LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM 2.0X7MM FOSSA X-DR SCRW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R