BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LACTO SCR 2.0X7MM 2.0 SYS 2/PK

    MDR report key: 2213997 · Received August 17, 2011

    Report

    Report Number
    1032347-2011-00103
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K955729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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. PLATE AND SCREWS WERE EXPLANTED IN THE SAME SURGERY, SEE MDR 1032347-2011-00101, 1032347-2011-00102, AND 1032347-2011-00104 ALSO. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY TO REMOVE THE IMPLANTS ON (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACTO SCR 2.0X7MM 2.0 SYS 2/PK BONE SCREW HWC BIOMET MICROFIXATION 711110

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization