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 Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
Our oem disrtibution rep stated ""xtant medical has received a product complaint from the streamline tl spinal fixation system, in which it was reported that two 5.5mm diameter screw implants (unknown product code/lot number) were identified as broken which will require 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.I am hoping to gather some additional incident and product information upon completion of the revision procedure, which has yet to occur but will provide any additional information gathered.-index procedure l4-l5 tlif performed (b)(6) 2021.-l5 screws malfunctioned january 2024.-revision procedure planned to remove broken screws and inner body because the cage is displaced and going into the spinal canal, date tbd".
Additional 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 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 5.5mm diameter screw implants (unknown product code/lot number) were identified as broken which will require a revision procedure.Xtant medical has initiated complaint 24-009 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.I am hoping to gather some additional incident and product information upon completion of the revision procedure, which has yet to occur but will provide any additional information gathered.Index procedure l4-l5 tlif performed (b)(6) 2021.L5 screws malfunctioned (b)(6) 2024.Revision procedure planned to remove broken screws and inner body because the cage is displaced and going into the spinal canal, date tbd".Information on the revision "(b)(6) 2024 explantation of l5 hardware, set screws, and rods.Placement of pedicle screws, bilateral s1.Explantation of protruding right l4-5 interbody graft.Right l4-5 facetectomy.L4-5 interbody fusion using trinity and morcellated autograft.Posterior instrumentation and fusion l4-5, l5-s1 bilaterally using rti pedicle screws and rods.Posterolateral fusion bilateral l4-5, l5-s1 using trinity and morcellated autograft".

• 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 MI 49855
• Manufacturer Contact: lyndsey rivord ; 375 river park circle; marquette
• MDR Report Key: 18731509
• Report Number: 1833824-2024-00027
• Device Sequence Number: 12159414
• Product Code: NKB
• UDI-Device Identifier: 00846468005573
• UDI-Public: (01)00846468005573(10)371916
• 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: 2021
• 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,Followup
• Report Date (Section B): 05/16/2024

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: 371916
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 02/19/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2020
• 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