BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELLA-P

    MDR report key: 1369127 · Received April 25, 2009

    Report

    Report Number
    3004719693-2009-00001
    Event Type
    Injury
    Date Received
    April 25, 2009
    Date of Event
    October 29, 2008
    Report Date
    April 25, 2009
    Manufacturer
    INNOVASIS, INC.
    Product Code
    MNI
    PMA / PMN Number
    K071921
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION WAS INCONCLUSIVE AS TO WHY THE LOCKING CAP WAS LOOSE.

    Description of Event or Problem · 1

    DISTRIBUTOR'S REP TELEPHONED ON THE EVENT DATE, AND REPORTED THAT SURGEON HAD OBSERVED BY X-RAY THAT A LOCKING CAP HAD COME OFF FROM A PEDICLE SCREW CONSTRUCT. SURGERY WAS SCHEDULED TO MAKE A REVISION OF THE CONSTRUCT. THE EVENT WAS CLASSIFIED AS A REPORTABLE EVENT AND FORMS WERE SENT TO THE REP TO PROVIDE DETAILS FOR THE REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention RODS| PEDICLE SCREWS| LOCKING CAPS