BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM

    MDR report key: 4051615 · Received September 2, 2014

    Report

    Report Number
    0001032347-2014-00281
    Event Type
    Injury
    Date Received
    September 2, 2014
    Report Date
    August 4, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK953385
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 POSSIBLE ADVERSE EFFECTS ARE "INTRAOPERATIVE AND EARLY POSTOPERATIVE COMPLICATIONS CAN INCLUDE: FRACTURE OF THE IMPLANT, FRACTURE OF BONE OR SOFT TISSUE DAMAGE, EXTRUSION OF THE IMPLANT, DEHISCENCE OF THE INCISION, PROMINENCE OR DISFIGUREMENT AT THE IMPLANT SITE, AND INFECTION. LATE POSTOPERATIVE COMPLICATIONS CAN INCLUDE: FRACTURE OF THE DEVICE DUE TO TRAUMATIC INJURY, LOOSENING OR MIGRATION DUE TO LOSS OF FIXATION OR TRAUMA, AND PROMINENCE OR DISFIGUREMENT OVER TIME AT OR NEAR THE IMPLANT SITE." 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 THREE OF THREE FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTS THE IMPLANT WAS REMOVED DUE TO AN ABSCESS THAT FORMED BENEATH THE IMPLANT. THE DATE OF THE REVISION SURGERY IS UNKNOWN. THE PATIENT IS SCHEDULED TO RECEIVE A NEW HTR PMMA IMPLANT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534915 LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM 1.5MM SCREW JEY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R