BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIALIGN

    MDR report key: 8333600 · Received February 12, 2019

    Report

    Report Number
    3007521480-2019-00004
    Event Type
    Injury
    Date Received
    February 12, 2019
    Report Date
    February 12, 2019
    Manufacturer
    ORTHALIGN INC.
    Product Code
    OLO
    PMA / PMN Number
    K163379
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE MONTH OF (B)(6) (2019) ORTHALIGN, INC. WAS MADE AWARE OF 6 PATIENTS WHO UNDERWENT UNICOMPARTMENTAL KNEE ARTHROPLASTY SURGERY THAT UTILIZED ORTHALIGN INC.'S ORTHALIGN PLUS®, UNIALIGN¿ SYSTEM PERFORMED BY DR. (B)(6) OF (B)(6) SURGERY CENTER AT (B)(6). THESE SIX PATIENTS WERE DISCOVERED TO HAVE INDUCED TIBIAL PLATEAU FRACTURES AT POST-OPERATIVE APPOINTMENTS. ONCE ORTHALIGN WAS MADE AWARE OF THESE CASES DR. (B)(6) WAS IMMEDIATELY CONTACTED TO GATHER MORE INFORMATION. THROUGH INVESTIGATING THESE SIX INCIDENCES ORTHALIGN CANNOT VERIFY THE INITIAL COMPLAINT REGARDING THE KNEEALIGN® 2 INSTRUMENTATION. A RISK ASSESSMENT WAS PERFORMED, AND INTERNAL RISK DOCUMENTS WERE REVIEWED. THE KNOWN RISK OF BONE FRACTURES IN UNICOMPARTMENTAL KNEE ARTHROPLASTY'S IS ADDRESSED SPECIFIC TO PIN PLACEMENT. THE PLACEMENT OF PINS PER THE INSTRUMENTATION INSTRUCTION HAS BEEN ASSESSED AND VALIDATED BY SURGEONS. THROUGH THE THIRD-PARTY INVESTIGATION PERFORMED WITH DR. (B)(6) ORTHALIGN GATHERED THE FOLLOWING INFORMATION: NO NOTED DEVICE DEFECTS OR MALFUNCTIONS WERE DETECTED. THE ORTHALIGN INSTRUMENTS PERFORMED AS EXPECTED. THE INSTRUMENTS HAVE ALSO BEEN USED IN OTHER CASES WITHOUT ANY PROBLEMS. THE UNIALIGN INSTRUMENTS WERE USED WITH THE ORTHALIGN PLUS UNIT AND KA2 INSTRUMENTS SET PER STANDARD PROCEDURE. THE SURGEON FIXATED THE INSTRUMENTATION APPROPRIATELY. NO NOTABLE INTRAOPERATIVE CHALLENGES AND OBSERVATIONS WERE DETECTED DURING THE CASE. NO COMPLICATING FACTORS WERE OBSERVED. NO OTHER RELEVANT PATIENT HISTORY OR MEDICAL CONDITIONS WAS NOTED. PATIENT X-RAYS AND TWO IMAGES FROM ONE OF THE CASES WERE RECEIVED. FRACTURES PROPAGATED AT THE PLATEAU BASE, BUT NOT FROM WHERE PINS WERE PLACED. THERE IS NO KNOWN CAUSE OF THE TIBIAL FRACTURES AND NO IMMEDIATE DEVICE RELATED CAUSE OR CONTRIBUTION TO THESE EVENTS. ORTHALIGN IS FILING THIS MDR IN AN ABUNDANCE OF CAUTION DUE TO THE OUTCOME OF THESE CASES AND THE POTENTIAL CONNECTION TO THE UNIALIGN¿ SYSTEM.

    Description of Event or Problem · 1

    ORTHALIGN EMPLOYEE REPORTED: PLACEMENT OF PINS THROUGH MULTIPLE HOLES IN KA2 TIBIAL JIG ARM AND/OR IN UNI MEDIAL CUTTING BLOCK ARE BELIEVED TO HAVE INDUCED A TIBIAL PLATEAU FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124952 UNIALIGN KNEEALIGN 2 INSTRUMENT KIT OLO ORTHALIGN INC. 402064 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other