BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELLA-P

    MDR report key: 1369198 · Received April 24, 2009

    Report

    Report Number
    3004719693-2009-00003
    Event Type
    Injury
    Date Received
    April 24, 2009
    Date of Event
    March 25, 2009
    Report Date
    April 24, 2009
    Manufacturer
    INNOVASIS, INC.
    Product Code
    MNI
    PMA / PMN Number
    K042143
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVAL WAS INCONCLUSIVE AS TO WHY THE LOCKING CAP LOOSENED.

    Description of Event or Problem · 1

    SALES REP CALLED AND REPORTED THAT LOCKING CAPS HAD COME LOOSE OVER TIME AFTER AN EARLIER SURGERY. MULTIPLE ATTEMPTS TO GET MORE DETAILED INFO WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELLA-P PEDICLE SCREW SYSTEM MNI INNOVASIS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCKING CAPS| PEDICLE SCREWS| RODS