BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPIDUS

    MDR report key: 11685067 · Received April 19, 2021

    Report

    Report Number
    3009540749-2021-00009
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    March 25, 2021
    Report Date
    April 19, 2021
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    PMA / PMN Number
    K190231
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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

    IT WAS REPORTED DURING A SURGERY INVOLVING THE LAPIDUS INCORE DISPOSABLE KIT 28L ON (B)(6) 2021 THAT THE POST ASSEMBLY WAS IN THE INCORRECT ORIENTATION. THE SURGEON COMPLETED THE SURGERY USING ANOTHER DEVICE, RESULTING IN A 1.5 HOUR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583002 INCORE LAPIDUS SCREW HWC NEXTREMITY SOLUTIONS 168B29619A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention