BEUDAMED
    FDA Adverse Event Summary report: N

    LACTOSORB 42X42 PANEL MESH

    MDR report key: 1905828 · Received November 23, 2010

    Report

    Report Number
    1032347-2010-00190
    Date Received
    November 23, 2010
    Date of Event
    August 4, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K955729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. CUSTOMER WAS ADVISED YOU HAVE TO PREDRILL / TAP INTO THE MESH PRIOR TO SCREW FIXATION.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE DOCTOR WAS ATTEMPTING TO INSERT THE SCREW INTO THE MESH PANEL, THE 2.0MM SCREW WAS UNABLE TO BE INSERTED. HE THEN TRIED THE 2.5MM EMERGENCY SCREW, WHICH HE WAS UNABLE TO GET THE SCREW THROUGH THE PLATE HOLE. THERE WAS A 30-40 MINUTE DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACTOSORB 42X42 PANEL MESH BONE PLATE HRS BIOMET MICROFIXATION 791060

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization