BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLT,OPENG WEDG OSTEO

    MDR report key: 17246916 · Received July 3, 2023

    Report

    Report Number
    1220246-2023-07020
    Event Type
    Injury
    Date Received
    July 3, 2023
    Date of Event
    June 5, 2023
    Report Date
    February 24, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    HRS
    UDI-DI
    00888867009752
    PMA / PMN Number
    K032187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT HAS NOT YET BEEN DETERMINED AS THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED, INCLUDING A MOST LIKELY CAUSE IF A ROOT CAUSE CAN NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6 THE COMPLAINT ALLEGATION IS CONFIRMED. BASED ON THE X-RAY SUBMITTED FOR EVALUATION, IT WAS NOTED THAT THE SCREW WAS BROKEN AND IMPLANTS WOULD HAVE TO BE EXPLANTED. CONSEQUENTLY, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE FOR THE COMPLAINT ALLEGATION. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-13380-42 CORTICAL SCREWS WERE FOUND BROKEN DURING A POST-OPERATIVE FOLLOW-UP. THE PROCEDURE WAS A HIGH TIBIAL OSTEOTOMY. THE PATIENT DID NOT HAVE ANY SIGNIFICANT COMPLAINTS AND DID NOT RECALL AN EVENT OR INJURY TO HAVE OCCURRED. A COLLAPSE WAS NOTICED IN THE PATIENT'S OSTEOTOMY SITE. THE IMPLANTS ARE STILL IN THE PATIENT, AND REVISION SURGERY HAS NOT HAPPENED YET. ADDITIONAL INFORMATION RECEIVED ON 6/8/2023: THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2023, AND REVISION SURGERY OCCURRED ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 6/16/2023: DURING THE REVISION SURGERY, AN AR-13200T-12.5 TIBIAL OPENING WEDGE OSTEOTOMY PLATE, TWO AR-13280-45 CANCELLOUS SCREW, AND THREE AR-13370-3 OSFERION OSTEOTOMY WEDGE WERE EXPLANTED ALONG WITH THE TWO BROKEN AR-13380-42 CORTICAL SCREWS. BOTH SURGERIES WERE PERFORMED AT THE SAME FACILITY AND BY THE SAME SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254477 PLT,OPENG WEDG OSTEO BONE FIXATION PLATE HRS ARTHREX, INC. PLT,OPENG WEDG OSTEO UNK 00888867009752

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other