BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPIDUS

    MDR report key: 10580307 · Received September 24, 2020

    Report

    Report Number
    3009540749-2020-00033
    Event Type
    Injury
    Date Received
    September 24, 2020
    Report Date
    September 24, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    PMA / PMN Number
    K180257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 COULD NOT BE PERFORMED, PART AND LOT NUMBERS WERE NOT PROVIDED. ROOT CAUSE IS POTENTIALLY DUE TO PATIENT FALLING, AS IT WAS REPORTED THE JOINT WAS FUSED AND THE POST REMAINED IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED. 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 FEMALE PATIENT HAD AN INCORE LAPIDUS IMPLANTED ON AN UNKNOWN DATE AND AT ABOUT 9 TO 10 MONTHS POST OP, THE PATIENT HAD FALLEN. AFTER THE FALL IT WAS NOTED THE SCREWS WERE BROKEN. THE SCREWS WERE REMOVED AT AN UNKNOWN DATE. NO PATIENT COMPLICATIONS REPORTED. THE POST REMAINED IMPLANTED AND IT WAS NOTED THE JOINT WAS FUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047057 INCORE LAPIDUS SCREW HWC NEXTREMITY SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention