BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAYPOINT STEREOTACTIC PLATFORM

    MDR report key: 17548901 · Received August 15, 2023

    Report

    Report Number
    3002250546-2023-00002
    Event Type
    Injury
    Date Received
    August 15, 2023
    Date of Event
    June 9, 2023
    Report Date
    August 14, 2023
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    UDI-DI
    00873263005903
    PMA / PMN Number
    K092192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FHC IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY FHC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. FHC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, FHC, OR ITS EMPLOYEES THAT THE DEVICE, FHC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. FHC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE PHYSICIAN REPORTED THAT MP-KIT-P-BI PLATFORM SN 50504 TRAJECTORY WAS OFF BY COUPLE MILLIMETERS IN THE ANTERIOR DIRECTION FOR BOTH SIDES. THE DOCTOR CONFIRMED WITH MER AND POST-OP CT. THE DOCTOR ALSO CONFIRMED THE PLATFORM, AND SCREWS WERE WELL SEATED. THE CASE WAS COMPLETED, AND THE DOCTOR DID NOT REPORT IMPACT TO THE PATIENT. FHC REVIEWED THE PLANS AND ASSOCIATED PRODUCT DOCUMENTATION AND DID NOT FIND ANY ERRORS THAT WOULD CORRELATE TO THIS ISSUE. ON (B)(6) 2023 THE PHYSICIAN REPORTED TO FHC THAT THE DBS LEAD WAS PLACED INACCURATELY ON (B)(6) WITH PLATFORM AND WAS NOT WORKING WELL AND HE WOULD PERFORMING REVISION SURGERY TO REPOSITION THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792908 WAYPOINT STEREOTACTIC PLATFORM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW FHC, INC. MP-KIT-P-BI 2401 00873263005903

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization