BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPIDUS

    MDR report key: 20025729 · Received August 22, 2024

    Report

    Report Number
    3009540749-2024-00016
    Event Type
    Injury
    Date Received
    August 22, 2024
    Report Date
    August 15, 2024
    Manufacturer
    MEDARTIS INC.
    Product Code
    HWC
    PMA / PMN Number
    K180257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COMPRESSION ON GUIDE WAS DEFICIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127570 INCORE LAPIDUS SCREW HWC MEDARTIS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown