MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGY STREAMLINE TL; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 01-PA-65-40

Device Problems Break (1069); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

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: a1-a6 b3 b6-b7 d6a-d7b d10 g5 g7 h2 h7 h9-h10.

Event Description

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 (b)(6) 2024 revision procedure) were identified as broken which required a revision procedure.Xtant medical has initiated complaint 24-008 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 (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 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 (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.".

Manufacturer Narrative

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.

Event Description

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 (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 (b)(6) 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 (b)(6) 2023; revision procedure for removal and replacement of implants on (b)(6) 2024 without complication.".

• Brand Name: PIONEER SURGICAL TECHNOLOGY STREAMLINE TL
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette MI 49855
• Manufacturer Contact: lyndsey rivord ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 18731447
• MDR Text Key: 335755132
• Report Number: 1833824-2024-00025
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00846468005641
• UDI-Public: (01)00846468005641(10)387549
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-PA-65-40
• Device Lot Number: 380167
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other