BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAYPOINT¿ SURGICAL KIT

    MDR report key: 21734311 · Received March 31, 2025

    Report

    Report Number
    3002250546-2025-00002
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    March 1, 2025
    Report Date
    March 31, 2025
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    UDI-DI
    00873263003046
    PMA / PMN Number
    K092192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 3/1 DR. (B)(6) INFORMED FHC REP. ABOUT A POSSIBLE FIDUCIAL INFECTION IN THE PATIENT (B)(6) (SN (B)(6)) DURING THE DBS PROCEDURE ON 2/27. HE SAID IT WAS THE ANTERIOR-RIGHT FIDUCIAL. HE WASN'T SURE IF IT WAS REALLY AN INFECTION OR FAT NECROSIS. THEY DIDN'T CULTURE IT, BUT PROCEEDED AS IF IT WAS AN INFECTION BY REMOVING THE FIDUCIAL AND CLEANING THE COMPROMISED AREA AND ISOLATING IT SO THE CASE DIDN'T CANCEL. DR. (B)(6) CONFIRMED THE PLATFORM WAS STABLE AND THE CASE WAS COMPLETED SUCCESSFULLY. PATIENT WILL COME BACK THE FOLLOWING WEEK TO GET THE IPG GENERATOR IMPLANTED. ON 3/18 FHC REACHED OUT TO DR. (B)(6) TO FOLLOW UP ON ANY UPDATES FROM THIS PATIENT AFTER HIS VISIT TO GET THE GENERATOR. DR. (B)(6) REPLIED AND SAID "SO FAR, NO ISSUES. HE CAME BACK FOR HIS SECOND STAGE PROCEDURE AND EVERYTHING LOOKED LIKE IT WAS HEALING APPROPRIATELY. WE WILL SEE HIM NEXT IN NEUROSURGERY IN A COUPLE OF MONTHS". THERE WAS NO INDICATION OF LARGER HARM TO THE PATIENT. THERE WAS NO INDICATION OF ANY FAILURE OR DEFECT OF THE ANCHOR SCREW (FIDUCIAL). PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832881 WAYPOINT¿ SURGICAL KIT NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW FHC, INC. 66-WP-SKS-00304 300064 00873263003046

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other