BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM

    MDR report key: 4051522 · Received September 2, 2014

    Report

    Report Number
    0001032347-2014-00278
    Event Type
    Injury
    Date Received
    September 2, 2014
    Report Date
    August 5, 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
    UK
    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. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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 THREE OF THREE FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THE PATIENT IS NOW SYMPTOMATIC TO THE ALLERGY OF NICKEL AND WILL HAVE A REVISION SURGERY. THE PATIENT HAD A NORMAL PATCH TEST, HOWEVER SHE DEVELOPED PAIN AND SWELLING AND HAS HAD A POSITIVE PATCH TEST. THE PATIENT WILL RECEIVE A TITANIUM IMPLANT, THE DATE OF THE REVISION SURGERY IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534812 LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM FOSSA SCREWS JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R