BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPIDUS SYSTEM

    MDR report key: 17297662 · Received July 11, 2023

    Report

    Report Number
    3009540749-2023-00005
    Event Type
    Injury
    Date Received
    July 11, 2023
    Date of Event
    June 12, 2023
    Report Date
    July 11, 2023
    Manufacturer
    MEDARTIS INC.
    Product Code
    HWC
    PMA / PMN Number
    K180257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS PROVIDED THAT CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IMPLANTATION WENT SMOOTHLY WITH NO NOTABLE COMPLICATIONS. AFTER REMOVING THE TARGETING GUIDE DR. (B)(6) WAS UNHAPPY WITH THE POST AS IT SAT PROUD ENOUGH TO CAUSE SOFT TISSUE IRRITATION. UNABLE TO CORRECT THE ISSUE HE REMOVED ZB IMPLANTS AND USED ARTHREX. I WOULD ASSUME THE PATIENT CONSENTED TO ZIMMER BIOMET INCORE LAPIDUS BUT HE RECEIVED ATHREX PLATES INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147553 INCORE LAPIDUS SYSTEM SCREW HWC MEDARTIS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other