BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPIDUS SYSTEM

    MDR report key: 16875739 · Received May 5, 2023

    Report

    Report Number
    3009540749-2023-00003
    Event Type
    Injury
    Date Received
    May 5, 2023
    Manufacturer
    MEDARTIS INC
    Product Code
    HWC
    PMA / PMN Number
    K180257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS AN INITIAL REPORT, THE INVESTIGATION HAS NOT BEEN COMPLETED AT THIS TIME. PRODUCT IS NOT BEING RETURNED FOR REVIEW, HOWEVER INVENTORY ITEMS ON HAND WHERE APPLICABLE WILL BE INSPECTED FOR CTQ DIMENSIONS, AND A FOLLOW UP REPORT WILL BE PROVIDED. ADDITIONALLY, INVESTIGATION CONCLUSIONS WILL BE PROVIDED IN THE FOLLOW UP REPORT.

    Description of Event or Problem · 0

    NON-UNION OF LAPIDUS. PROXIMAL SCREW BROKEN AND ALL INCORE HARDWARE REMOVED. REVISION MID-FOOT ARTHRODESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212640 INCORE LAPIDUS SYSTEM SCREW HWC MEDARTIS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other IC-LAP-3528 R17632IC-LAP-3544 R17296| IC-LAP-3544 R17296| IC-LAP-35P 162071| IC-LAP-D36 168A03122A| IC-LAP-T10 168A322190