BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPIDUS SYSTEM

    MDR report key: 10994761 · Received December 12, 2020

    Report

    Report Number
    3009540749-2020-00046
    Event Type
    Injury
    Date Received
    December 12, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 11, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    PMA / PMN Number
    180257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 PATIENT NON-COMPLIANCE TO SURGEONS POST OPERATIVE INSTRUCTIONS. 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

    ON AN UNKNOWN DATE A PATIENT WAS IMPLANTED WITH AN INCORE LAPIDUS 5.9MM LEFT POST, A 3.5 X 5MM SCREW AND A 3.5 X 38MM SCREW. TWO WEEKS POST-OP THE PATIENT WAS COMPLAINING OF PAIN. SURGEON TOOK A X-RAY AND DETERMINED BOTH SCREWS WERE BROKEN. PATIENT ADMITTED TO FULL WEIGHT BEARING ON FOOT. REVISION SURGERY WAS DONE ON (B)(6) 2020 BY THE SAME SURGEON. PIECES OF THE BROKEN SCREWS WERE EXTRACTED, HOWEVER THE POST WITH THE BITS OF SCREWS REMAIN IMPLANTED. SURGEON REVISED PATIENT USING A STRATUM MEDIAL FUSION PLATE. REVISION SURGERY WAS SUCCESSFUL. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459529 INCORE LAPIDUS SYSTEM SCREW HWC NEXTREMITY SOLUTIONS R17672, R17708

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention