BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPIDUS SYSTEM

    MDR report key: 9330947 · Received November 15, 2019

    Report

    Report Number
    3009540749-2019-00015
    Event Type
    Injury
    Date Received
    November 15, 2019
    Report Date
    November 15, 2019
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    PMA / PMN Number
    K180257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NEXTREMITY SOLUTIONS BECAME AWARE OF THIS EVENT WHEN AN EMPLOYEE HEARD A SALES REPRESENTATIVE MENTION AN INCORE LAPIDUS REMOVAL. DURING FOLLOW-UP COMMUNICATION, THE SALES REPRESENTATIVE REPORTED THAT FUSION HAD BEEN ACHIEVED, AND THAT THE PATIENT HAD REQUESTED THE DEVICE TO BE REMOVED BECAUSE THE POST WAS "PROUD" AND COULD BE FELT BY THE PATIENT. THERE WAS NO ALLEGED MALFUNCTION OR DEFICIENCY WITH THE DEVICE.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH THE INCORE LAPIDUS SYSTEM. SOME TIME AFTER SURGERY, IT WAS REPORTED THAT FUSION WAS ACHIEVED AND THAT THE PATIENT REQUESTED FOR THE INCORE LAPIDUS SYSTEM TO BE REMOVED. THE INCORE LAPIDUS SYSTEM WAS REMOVED PER THE SURGICAL TECHNIQUE WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1120852 INCORE LAPIDUS SYSTEM POST, SCREWS HWC NEXTREMITY SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other