BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIONEER SURGICAL TECHNOLOGY FORTILINK C

    MDR report key: 12488532 · Received September 17, 2021

    Report

    Report Number
    1833824-2021-00076
    Event Type
    Death
    Date Received
    September 17, 2021
    Report Date
    September 17, 2021
    Manufacturer
    PIONEER SURGICAL TECHNOLOGY
    Product Code
    MAX
    UDI-DI
    00846468080341
    PMA / PMN Number
    K190498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR THIS COMPLAINT. THEREFORE, NO DEVICE INVESTIGATION COULD BE DONE OTHER THAN A REVIEW OF THE MANUFACTURING RECORDS RELATED TO THE PART. ACCORDING TO THE DHR, THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS. REPEATED INQUIRES TO GATHER MORE INFORMATION ABOUT THIS CASE HAVE NOT RESULTED IN ANY ADDITIONAL INFORMATION BEYOND WHAT IS LISTED IN THIS REPORT. BASED ON THE INFORMATION GATHERED FROM THIS OCCURRENCE, THERE IS NO EVIDENCE THAT PIONEER SURGICAL'S DEVICE NOR THE PROCEDURE WERE THE CAUSE OF THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    ON (B)(6) 2021, IT WAS REPORTED TO PIONEER SURGICAL TECHNOLOGY THAT A DEATH HAD OCCURRED FOR A PATIENT THAT WAS ENROLLED IN A POST MARKET RETROSPECTIVE CLINICAL STUDY. BASED ON THE LIMITED INFORMATION RECEIVED BY PIONEER SURGICAL TECHNOLOGY, THE PATIENT REPORTEDLY DIED OF A STROKE ON (B)(6) 2020. INITIAL SURGERY FOR THIS PATIENT WAS ON (B)(6) 2019. THERE WAS NO REPORTED EVIDENCE THAT THIS DEATH WAS CAUSED BY THE SURGERY OR PIONEER SURGICAL TECHNOLOGY'S IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388253 PIONEER SURGICAL TECHNOLOGY FORTILINK C INTERBODY FUSION DEVICE MAX PIONEER SURGICAL TECHNOLOGY 65-C-1214-6-6L 329592 00846468080341

    Patients

    Seq Age Sex Outcome Treatment
    1 Death