BEUDAMED
    FDA Adverse Event Summary report: N

    LACTOSORB SCREW 2.0X7MM 2 PACK

    MDR report key: 2231741 · Received September 1, 2011

    Report

    Report Number
    1032347-2011-00107
    Date Received
    September 1, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 18, 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 1032347-2011-00106 ALSO.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD LACTOSORB PLATES AND SCREWS IMPLANTED ON (B)(6) 2011. ON (B)(6) 2011 THE DOCTOR FOUND THAT THE PLATE BECAME EXPOSED IN THE MOUTH AND A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACTOSORB SCREW 2.0X7MM 2 PACK BONE SCREW HWC BIOMET MICROFIXATION 448860

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization