BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPIDUS SYSTEM

    MDR report key: 11294813 · Received February 8, 2021

    Report

    Report Number
    3009540749-2021-00004
    Event Type
    Injury
    Date Received
    February 8, 2021
    Date of Event
    December 23, 2020
    Report Date
    February 8, 2021
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    PMA / PMN Number
    K180257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT REVIEW / INVESTIGATION COULD NOT BE PERFORMED SINCE PRODUCT WAS NOT RETURNED. DEVICE HISTORY RECORD REVIEW FOUND NO RELATED NONCONFORMANCES AND THE DOCUMENTATION SHOWS NO EVIDENCE OF ABNORMALITIES. ROOT CAUSE IS UNKNOWN. 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 A PATIENT HAD PERSISTENT PLANTAR PAIN BELIEVED TO HAVE BEGAN 4 TO 5 WEEKS POST OP. ON (B)(6) 2020 THE SURGEON DECIDED TO REMOVE INCORE LAPIDUS IMPLANTS THAT WERE IMPLANTED ON AN UNKNOWN DATE. UPON REMOVAL OF THE INCORE LAPIDUS SYSTEM THE SURGEON NOTED THE SCREWS WERE BROKEN. THE BROKEN SCREW ENDS REMAINED IN THE POST AND CUNIEFORM. SURGEON EXPERIENCED DIFFICULTY REMOVING THE POST AND SCREW TIPS UTILIZING THE BACK SLAP TECHNIQUE. THE POST AND BROKEN SCREW PIECES WERE REMOVED FROM THE PATIENT AND REVISION WAS COMPLETED WITH BONE GRAFT AND BY A CROSSING LAG SCREW AND PLATE. PATIENT IS REPORTED AS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192256 INCORE LAPIDUS SYSTEM SCREW HWC NEXTREMITY SOLUTIONS 168B29619B

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention