BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOUNDATION LATERAL

    MDR report key: 13826487 · Received March 19, 2022

    Report

    Report Number
    3006494201-2022-00004
    Event Type
    Malfunction
    Date Received
    March 19, 2022
    Date of Event
    March 4, 2022
    Report Date
    March 18, 2022
    Manufacturer
    CORELINK SURGICAL, LLC
    Product Code
    KWQ
    PMA / PMN Number
    K190016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE LOT NUMBER WAS NOT PROVIDED, PRODUCTION RECORDS WERE NOT ABLE TO BE REVIEWED. AS THE PART NUMBER WAS ALSO NOT PROVIDED, A HISTORICAL REVIEW OF ALL DEVICES INCLUDED IN DRAWING 900215-XX WAS CONDUCTED. IT WAS DETERMINED IN THE PAST YEAR THERE HAS BEEN ONE REPORT FILED FOR THIS REPORTED ISSUE, BUT IT WAS DETERMINED TO BE A NON-COMPLAINT. A ROOT CAUSE OF THE NONCONFORMANCE WAS NOT ABLE TO BE ESTABLISHED AT THIS TIME. AS THE PHYSICIAN IS NOT PLANNING TO REOPERATE AND THE PATIENT IS NOT EXPERIENCING ANY ADVERSE EFFECTS, THIS IS BEING CONSIDERED AN ISOLATED INCIDENT.

    Description of Event or Problem · 0

    DURING A 6 MONTH POST OPERATION CHECK UP, THE X-RAY SHOWED A SET SCREW FLOATING OUTSIDE OF THE PLATE. THE PATIENT IS NOT EXPERIENCING ANY ADVERSE EVENTS FROM THIS, AND THE PHYSICIAN DOES NOT INTEND TO PERFORM A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582294 FOUNDATION LATERAL ORO LATERAL PLATE - 2 SCREW KWQ CORELINK SURGICAL, LLC EXACT PLATE NUMBER UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown