BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCORE LAPIDUS SYSTEM

    MDR report key: 10977607 · Received December 9, 2020

    Report

    Report Number
    3009540749-2020-00045
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 4, 2020
    Report Date
    December 9, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    PMA / PMN Number
    K180257
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS RELATED TO THE EVENT WERE REVIEWED. THERE WERE NO NON-CONFORMANCES DETECTED THROUGH THE DEVICE HISTORY RECORD REVIEW. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A PROCEDURE WITH THE INCORE LAPIDUS SYSTEM ON (B)(6) 2020 THE MEDIAL SCREW WENT IN WITHOUT ANY ISSUES, BUT THE LATERAL SCREW WOULD NOT ENGAGE WITH THE POST. THE SURGEON REDRILLED THE HOLE AND STILL WAS NOT ABLE TO GET THE LATERAL SCREW TO ENGAGE WITH THE POST. THE SURGEON THEN ATTEMPTED TO USE A SHORTER SCREW AND THAT SCREW DID NOT ENGAGE THE POST EITHER. THE POST AND MEDIAL SCREW REMAIN IMPLANTED IN THE PATIENT. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1444458 INCORE LAPIDUS SYSTEM SCREW HWC NEXTREMITY SOLUTIONS R18160

    Patients

    Seq Age Sex Outcome Treatment
    1