BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIONEER SURGICAL TECHNOLOGY STREAMLINE TL

    MDR report key: 18859552 · Received March 7, 2024

    Report

    Report Number
    1833824-2024-00030
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    June 21, 2023
    Report Date
    March 7, 2024
    Manufacturer
    PIONEER SURGICAL TECHNOLOGY
    Product Code
    NKB
    UDI-DI
    00846468005658
    PMA / PMN Number
    K140696
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    "DEVICE WAS NOT RETURNED TO RESOLVE SURGICAL FOR INSPECTION. MULTIPLE ATTEMPTS WERE MADE TO GATHER DATA FROM THE REP. NO ADDITIONAL INFORMATION OR CONFIRMATION HAS BEEN GIVEN THAT THIS IS A PIONEER SURGICAL TECHNOLOGIES MANUFACTURED PART. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN LEFT BLANK DUE TO THE INFORMATION BEING UNAVAILABLE OR NON-APPLICABLE:

    Description of Event or Problem · 0

    OUR OEM DISTRIBUTION REP STATED "XTANT MEDICAL HAS RECEIVED A PRODUCT COMPLAINT FROM THE STREAMLINE TL SPINAL FIXATION SYSTEM, IN WHICH IT WAS REPORTED THAT TWO PEDICLE SCREW IMPLANTS (01-PA-65-45, LOTS 381268 AND 380862) WERE IDENTIFIED AS BROKEN, WHICH REQUIRED A REVISION PROCEDURE. XTANT MEDICAL HAS INITIATED COMPLAINT (B)(4) ON THE ISSUE. ATTACHED IS THE IMAGING PROVIDED BY THE COMPLAINT SOURCE. BELOW IS RELEVANT INFORMATION PROVIDED BY THE COMPLAINT SOURCE, PLEASE LET ME KNOW IF YOU HAVE ANY QUESTIONS OR CONCERNS, APPRECIATE THE ASSISTANCE. COMMENTARY PROVIDED: PATIENT WAS IMPLANTED (B)(6) 2023, ON (B)(6) 2023 PATIENT CAME IN AND REPORTS 95% IMPROVED AND WAS PLEASED WITH SURGERY RESULT. ON APPROXIMATELY (B)(6) 2024 A STRANGE SQUEAKING NOISE BEGAN. ON (B)(6) 2024 CT SCAN SHOWS VERTICAL NONDISPLACED FRACTURES THROUGH THE BILATERAL S1 PEDICLE SCREWS AT BOTH OSSEOUS ENTRY POINTS. INDEX PROCEDURE PERFORMED (B)(6) 2023, REVISION PROCEDURE PERFORMED (B)(6) 2024".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196477 PIONEER SURGICAL TECHNOLOGY STREAMLINE TL THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB PIONEER SURGICAL TECHNOLOGY 01-PA-65-45 380862 00846468005658

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other