BEUDAMED
    FDA Adverse Event Summary report: N

    1.5X6MM HT SD X-DR SCR

    MDR report key: 1813440 · Received August 24, 2010

    Report

    Report Number
    1032347-2010-00130
    Date Received
    August 24, 2010
    Report Date
    August 12, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    K953385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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. WE RECEIVED NOTICE APPROXIMATELY 100 SCREWS BREAKING, TIPS BEING LEFT IN THE PATIENTS. THIS OCCURRED FROM (B)(6) 2009-(B)(6) 2010, IN 5 DIFFERENT HOSPITALS, IN 15 DIFFERENT SURGERIES. PLEASE SEE MDR 1032347-2010-00129 TO 1032347-2010-00144.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE DOCTOR WAS IMPLANTING SCREWS, SOME BROKE. THE TIP OF THE SCREW REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5X6MM HT SD X-DR SCR BONE SCREW HWC BIOMET MICROFIXATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1