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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGY STREAMLINE TL; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGY STREAMLINE TL; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 01-PA-55-45
Device Problem Break (1069)
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.
 
Event 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".
 
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 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".
 
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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 
MDR Report Key18731509
MDR Text Key335737302
Report Number1833824-2024-00027
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140696
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number01-PA-55-45
Device Lot Number371916
Was Device Available for Evaluation? No
Date Manufacturer Received02/02/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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