BEUDAMED
    FDA Adverse Event Other Summary report: N

    LACTOSORB 2.0X5MM SUSPENSION PUSH SCREW, 2PK

    MDR report key: 1141392 · Received August 19, 2008

    Report

    Report Number
    1032347-2008-00049
    Event Type
    Other
    Date Received
    August 19, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 25, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO OTHER COMPLAINTS OF THIS NATURE HAVE BEEN RECEIVED. PRODUCT WAS LEFT IN PATIENT, WHICH WILL RESORB, THEREFORE, UNABLE TO EVALUATE. 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. ALSO SEE REPORT #1032347-2008-00048 (SAME PROCEDURE, DIFFERENT MANUFACTURE LOT OF PRODUCT).

    Description of Event or Problem · 1

    RESORBABLE SCREWS WERE IMPLANTED (ENDOBROW LIFT) IN 2008. APPROXIMATELY 2 WEEKS AFTER SURGERY, PATIENT NOTICED BROWS WERE DOWN WHERE THEY WERE PRIOR TO SURGERY. REVISION SURGERY WAS DONE IN JULY (EXACT DATE NOT KNOWN) WHERE IT WAS DISCOVERED A SCREW OVER EACH EYE HAD FRACTURED. THE DOCTOR LEFT THE THREADED PORTION OF THE SCREWS (RESORBABLE) IN THE PATIENT, AS THEY WERE FLUSH WITH THE SKULL, AND THERE WAS NO WAY TO REMOVE. THE DOCTOR MADE NEW HOLES, IMPLANTED NEW SCREWS, AND THE PATIENT HAS NOT HAD ANY ADDITIONAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACTOSORB 2.0X5MM SUSPENSION PUSH SCREW, 2PK RESORABLE SCREW MAI BIOMET MICROFIXATION 772800

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization