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

Model Number	01-PA-55-45
Medical Device Problem Codes	Break (1069); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Our oem distribution rep "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-55-45, lots 378753 and 388226) were identified as broken, which required a revision procedure.Xtant medical has initiated complaint 24-024 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 performed (b)(6) 2022, revision procedure performed (b)(6) 2024".
Additional Manufacturer Narrative
"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: a1-a6, b3, b6-b7, d6a, g5, g7-g8, h2, h7, h9-h10.

• Brand Name: PIONEER SURGICAL TECHNOLOGY STREAMLINE TL
• Common Device Name: 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
• Manufacturer Contact: lyndsey rivord ; 375 river park circle; marquette
• MDR Report Key: 18859262
• Report Number: 1833824-2024-00035
• Device Sequence Number: 15543736
• Product Code: NKB
• UDI-Device Identifier: 00846468005573
• UDI-Public: (01)00846468005573(10)378753
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01-PA-55-45
• Device Lot Number: 378753
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown