BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIBOTICS KNEE SYSTEM

    MDR report key: 8121919 · Received December 1, 2018

    Report

    Report Number
    1226188-2018-00179
    Event Type
    Injury
    Date Received
    December 1, 2018
    Date of Event
    November 6, 2018
    Report Date
    November 9, 2018
    Manufacturer
    OMNILIFE SCIENCE, INC.
    Product Code
    OLO
    PMA / PMN Number
    K090953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT MADE NO INDICATION OF ANY OMNILIFE SCIENCE DEVICE MALFUNCTION OR DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR DEVICE PERFORMANCE CONTRIBUTING TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A PRIMARY KNEE SURGERY ON (B)(6) 2018. DURING THE CASE, A 4 TO 6MM FEMORAL NOTCH WAS CUT INTO THE BONE UNEXPECTEDLY. PATIENT BONE WAS SOFT, AND THE CUTTING BLOCK AND PINS SHIFTED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962438 OMNIBOTICS KNEE SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO OMNILIFE SCIENCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization