BEUDAMED
    FDA Adverse Event Other Summary report: N

    LACTOSORB 2.0X5MM SUSPENSION PUSH SCREW, 2PK

    MDR report key: 1141383 · Received August 19, 2008

    Report

    Report Number
    1032347-2008-00048
    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 REC'D. PRODUCT WAS LEFT IN PT, WHICH WILL RESORB, THEREFORE, UNABLE TO EVALUATE. CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFO 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 #1032347-2008-00049 (SAME PROCEDURE, DIFFERENT MFR LOT OF PRODUCT).

    Description of Event or Problem · 1

    RESORBABLE SCREWS WERE IMPLANTED (ENDOBROW LIFT) IN (B) (6) 2008. APPROXIMATELY 2 WEEKS AFTER SURGERY, PT NOTICED BROWS WERE DOWN WHERE THEY WERE PRIOR TO SURGERY. REVISION SURGERY WAS DONE IN (B) (6) (EXACT DATE NOT KNOWN) WHERE IT WAS DISCOVERED A SCREW OVER EACH EYE HAD FRACTURED. THE DR LEFT THE THREADED PORTION OF THE SCREWS (RESORBABLE) IN THE PT, AS THEY WERE FLUSH WITH THE SKULL AND THERE WAS NO WAY TO REMOVE THEM. THE DR MADE NEW HOLES, IMPLANTED NEW SCREWS, AN THE PT HAD NOT HAD ANY ADDITIONAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LACTOSORB 2.0X5MM SUSPENSION PUSH SCREW, 2PK RESORBABLE SCREW MAI BIOMET MICROFIXATION 981190

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization