BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPIDUS SYSTEM

    MDR report key: 9795188 · Received March 5, 2020

    Report

    Report Number
    3009540749-2020-00011
    Event Type
    Injury
    Date Received
    March 5, 2020
    Report Date
    March 5, 2020
    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

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

    Description of Event or Problem · 1

    A SURGERY WAS PERFORMED WITH THE INCORE LAPIDUS SYSTEM ON AN UNKNOWN DATE, AND IT WAS REPORTED THAT ONE OF THE SCREWS BROKE SOMETIME AFTER THE SURGERY. PER THE REPORTER THE BROKEN SCREW COULD BE EITHER A 32MM, 34MM OR 48MM 3.5 INCORE LAPIDUS COMPERSSION SCREW. ON (B)(6) 2020 THE INCORE LAPIDUS SYSTEM WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED FROM THE REMOVAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258303 INCORE LAPIDUS SYSTEM BONE SCREW HWC NEXTREMITY SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other