BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIONEER SURGICAL TECHNOLOGY STREAMLINE TL

    MDR report key: 18731459 · Received February 19, 2024

    Report

    Report Number
    1833824-2024-00026
    Event Type
    Injury
    Date Received
    February 19, 2024
    Report Date
    March 4, 2024
    Manufacturer
    PIONEER SURGICAL TECHNOLOGY
    Product Code
    NKB
    UDI-DI
    00846468005641
    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 AS. NO ADDITIONAL INFORMATION OR CONFIRMATION HAS BEEN GIVEN THAT THIS IS A PIONEER SURGICAL TECHNOLOGIES MANUFACTURED PART.

    Additional Manufacturer Narrative · 0

    DEVICE WAS NOT RETURNED TO RESOLVE SURGICAL FOR INSPECTION. MULTIPLE ATTEMPTS WERE MADE TO GATHER DATA FROM THE REP AS. 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 PARTNER "XTANT MEDICAL HAS RECEIVED A PRODUCT COMPLAINT FROM THE STREAMLINE TL SPINAL FIXATION SYSTEM, IN WHICH IT WAS REPORTED THAT TWO 6.5 X 40MM SCREW IMPLANTS (UNKNOWN PRODUCT CODE, LOTS 380167T AND 387549T IDENTIFIED DURING 1/24/24 REVISION PROCEDURE) 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. INDEX PROCEDURE L4-L5 PERFORMED (B)(6) 2020. ADDITIONAL PROCEDURE FOR EXTENSION OF FUSION TO S1 ON (B)(6) 2023. S1 SCREWS MALFUNCTIONED SOMETIME BETWEEN SEPTEMBER AND DECEMBER OF 2023. REVISION PROCEDURE FOR" XTANT MEDICAL HAS RECEIVED A PRODUCT COMPLAINT FROM THE STREAMLINE TL SPINAL FIXATION SYSTEM, IN WHICH IT WAS REPORTED THAT TWO 6.5 X 40MM SCREW IMPLANTS (UNKNOWN PRODUCT CODE, LOTS 380167T AND 387549T IDENTIFIED DURING (B)(6) 2024 REVISION PROCEDURE) 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. INDEX PROCEDURE L4-L5 PERFORMED (B)(6) 2020. ADDITIONAL PROCEDURE FOR EXTENSION OF FUSION TO S1 ON (B)(6), 2023. S1 SCREWS MALFUNCTIONED SOMETIME BETWEEN SEPTEMBER AND DECEMBER OF 2023 REVISION PROCEDURE FOR REMOVAL AND REPLACEMENT OF IMPLANTS ON (B)(6) 2024 WITHOUT COMPLICATION."

    Description of Event or Problem · 0

    OUR OEM DISTRIBUTION PARTNER "XTANT MEDICAL HAS RECEIVED A PRODUCT COMPLAINT FROM THE STREAMLINE TL SPINAL FIXATION SYSTEM, IN WHICH IT WAS REPORTED THAT TWO 6.5 X 40MM SCREW IMPLANTS (UNKNOWN PRODUCT CODE, LOTS 380167T AND 387549T IDENTIFIED DURING 1/24/24 REVISION PROCEDURE) 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. INDEX PROCEDURE L4-L5 PERFORMED OCTOBER 2020 ADDITIONAL PROCEDURE FOR EXTENSION OF FUSION TO S1 ON JULY 19, 2023 S1 SCREWS MALFUNCTIONED SOMETIME BETWEEN SEPTEMBER AND DECEMBER OF 2023 REVISION PROCEDURE FOR" XTANT MEDICAL HAS RECEIVED A PRODUCT COMPLAINT FROM THE STREAMLINE TL SPINAL FIXATION SYSTEM, IN WHICH IT WAS REPORTED THAT TWO 6.5 X 40MM SCREW IMPLANTS (UNKNOWN PRODUCT CODE, LOTS 380167T AND 387549T IDENTIFIED DURING 1/24/24 REVISION PROCEDURE) 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. INDEX PROCEDURE L4-L5 PERFORMED OCTOBER 2020 ADDITIONAL PROCEDURE FOR EXTENSION OF FUSION TO S1 ON JULY 19, 2023 S1 SCREWS MALFUNCTIONED SOMETIME BETWEEN SEPTEMBER AND DECEMBER OF 2023 REVISION PROCEDURE FOR REMOVAL AND REPLACEMENT OF IMPLANTS ON (B)(6) 2024 WITHOUT COMPLICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424399 PIONEER SURGICAL TECHNOLOGY STREAMLINE TL THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB PIONEER SURGICAL TECHNOLOGY 01-PA-65-40 387549 00846468005641

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other