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

Model Number	01-PA-65-45
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)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
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.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 on (b)(6) 2023, on (b)(6) 2023, patient came in and reports 95% improved and was pleased with surgery result.On approximately on (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 on (b)(6) 2023.Revision procedure performed on (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.

• 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
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY; 375 river park circle; marquette
• Manufacturer Contact: lyndsey rivord ; 375 river park circle; marquette
• MDR Report Key: 18860013
• Report Number: 1833824-2024-00031
• Device Sequence Number: 8239756
• Product Code: NKB
• UDI-Device Identifier: 00846468005658
• UDI-Public: (01)00846468005658(10)381268
• 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 Implanted Year: 2023
• 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-65-45
• Device Lot Number: 381268
• 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: 10/05/2020
• 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