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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 03/06/2024
Event Type  Injury  
Manufacturer Narrative
"device was not returned to resolve surgical for inspection.Part and batch information remains unknown at this time.Multiple attempts were made to gather data from the rep as well as the hospital that had information on the patient.No additional information or confirmation has been given that this is a pioneer surgical technologies manufactured part.
 
Event Description
Xtant rep reported that "on (b)(6) 2024 dr.(b)(6) sent an email to rtix for the following request "on (b)(6) 2024 we have a patient for revision surgery and need a loaner sieve to remove rti streamline material." the email was sent to resolve surgical and we will now reach out to xtant who ships the devices to their reps and try to get more information.I receive this from the complaint source, and again this morning have asked which specific streamline system this is for.I'll let you know as soon as they provide the information, but they did confirm it was due to adjacent level needs, and not in relation to any failure of the unknown streamline system."they told him that streamline was only removed because the adjacent segment needed to be fused and the surgeon basically wanted to work with a medtronic product.There was no implant failure or any other failure of streamline.For this reason, we will not receive any additional information."".
 
Manufacturer Narrative
"device was not returned to resolve surgical for inspection.Part and batch information remains unknown at this time.Multiple attempts were made to gather data from the rep as well as the hospital that had information on the patient.No additional information or confirmation has been given that this is a pioneer surgical technologies manufactured part.
 
Event Description
Xtant rep reported that "on (b)(6) 2024 dr.(b)(6) sent an email to rtix for the following request "on (b)(6) 2024 we have a patient for revision surgery and need a loaner sieve to remove rti streamline material." the email was sent to resolve surgical and we will now reach out to xtant who ships the devices to their reps and try to get more information.I receive this from the complaint source, and again this morning have asked which specific streamline system this is for.I'll let you know as soon as they provide the information, but they did confirm it was due to adjacent level needs, and not in relation to any failure of the unknown streamline system."they told him that streamline was only removed because the adjacent segment needed to be fused and the surgeon basically wanted to work with a medtronic product.There was no implant failure or any other failure of streamline.For this reason, we will not receive any additional information."".
 
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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, MI 49855
MDR Report Key18985714
MDR Text Key338692081
Report Number1833824-2024-00041
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/17/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received02/28/2024
Was Device Evaluated by Manufacturer? No
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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