BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRAXIM

    MDR report key: 5243093 · Received November 23, 2015

    Report

    Report Number
    1226188-2015-00092
    Event Type
    Malfunction
    Date Received
    November 23, 2015
    Date of Event
    October 12, 2015
    Report Date
    October 23, 2015
    Manufacturer
    OMNILIFE SCIENCE
    Product Code
    OLO
    PMA / PMN Number
    K090953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A REUSABLE INSTRUMENT NOT INTENDED TO BE IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IN AN ORIGINAL IMPLANT SURGERY DATED (B)(6) 2015, THE TIP OF A TIBIAL DRILL PIN BROKE OFF INSIDE THE TIBIA DURING THE PROCEDURE. THE IMPLANTS AND THE JOINT WERE CEMENTED INPLACE AND THE PIN WAS NOTICED POST SURGERY, DURING X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772457 PRAXIM IMAGE GUIDED SURGICAL NAVIGATION SYSTEM OLO OMNILIFE SCIENCE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization