BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHALIGN PLUS

    MDR report key: 7011820 · Received November 8, 2017

    Report

    Report Number
    3007521480-2017-00005
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    August 11, 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 INITIAL PROCEDURE WITH THE SURGEON. NO DEVICE DEFECTS OR MALFUNCTIONS WERE DETECTED. NO FRACTURE OR OTHER COMPLICATIONS WERE OBSERVED DURING THE INITIAL PROCEDURE. THE ORTHALIGN PLUS DEVICE PERFORMED NORMALLY DURING THE PROCEDURE. X-RAYS WERE NOT PROVIDED TO ORTHALIGN. IT IS UNCLEAR WHERE THE FRACTURE ORIGINATED IN THE TIBIA. IT IS UNCLEAR WHAT SPECIFICALLY CAUSED THE FRACTURE.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT A PATIENT WHO HAD UNDERGONE AN UNICOMPARTMENTAL KNEE ARTHROPLASTY PROCEDURE NAVIGATED BY THE ORTHALIGN PLUS SYSTEM RETURNED THREE AND A HALF MONTHS LATER WITH A FRACTURE IN THE TIBIA BELOW THE TIBIAL RESECTION. THE FRACTURE REQUIRED A REVISION PROCEDURE WITH A LONG TIBIAL STEM TO CONSTRAIN THE ARTHROPLASTY COMPONENTS AND BYPASS THE FRACTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788768 ORTHALIGN PLUS COMPUTER ASSISTED SURGERY SYSTEM OLO ORTHALIGN, INC. 403001 NA 00858704006534

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other