BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHALIGN PLUS

    MDR report key: 7012102 · Received November 8, 2017

    Report

    Report Number
    3007521480-2017-00006
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    September 12, 2017
    Report Date
    November 8, 2017
    Manufacturer
    ORTHALIGN, INC.
    Product Code
    OLO
    UDI-DI
    00858704006534
    PMA / PMN Number
    K171780
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WE REVIEWED THE ISSUE AND PROCEDURE WITH THE SURGEON. NO DEVICE DEFECTS OR MALFUNCTIONS WERE DETECTED. THE ORTHALIGN PLUS DEVICE PERFORMED NORMALLY DURING THE PROCEDURE. X-RAYS WERE NOT PROVIDED TO ORTHALIGN. THE FRACTURE APPARENTLY HAPPENED WHILE PLACING THE MOUNTING PINS FOR THE CUTTING BLOCK.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A FRACTURE IN THE TIBIA OCCURRED DURING PLACEMENT OF THE TIBIAL CUTTING BLOCK DURING AN UNICOMPARTMENTAL KNEE ARTHROPLASTY PROCEDURE NAVIGATED BY THE ORTHALIGN PLUS SYSTEM. THE FRACTURE REQUIRED USE OF A SMALL FRAGMENT PLATE AND SCREWS TO STABILIZE THE PROXIMAL TIBIA BELOW THE RESECTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790043 ORTHALIGN PLUS COMPUTER ASSISTED SURGERY SYSTEM OLO ORTHALIGN, INC. 403001 NA 00858704006534

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other