BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE PROBE, LENKE

    MDR report key: 2051076 · Received April 5, 2011

    Report

    Report Number
    1649384-2011-00027
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ZIMMER SPINE
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS EXPECTED TO BE RETURNED BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE TIP OF THE PEDICLE PROBE BROKE IN THE PATIENT. THE SURGEON WAS UNABLE TO RETRIEVE IT AND IT REMAINS IN THE SACRUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDICLE PROBE, LENKE PEDICLE PROBE LXH ZIMMER SPINE 3352-3 47NX

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other