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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGY STREAMLINE MIS PEDICLE SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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PIONEER SURGICAL TECHNOLOGY PIONEER SURGICAL TECHNOLOGY STREAMLINE MIS PEDICLE SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
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
Surgalign associate product manager, christopher marshall sent the following complaint, "an engineer brought to my attention a screw failure at the screw neck via a screenshot of a facebook or social media.The screw failure looks like it was apart of the streamline mis system and a 05-pa part number.The engagement feature on the mis rod, the tulip profile, and set screw profile in the x-ray provides evidence it may be streamline mis.The only information provided was the x-ray along with the individual via facebook.The individuals company she works for was found through a search of her profile on linkedin.".
 
Event Description
"it was reported that on an unknown date, there is a 4 level acdf.The screw backed out of plate, patient will need a revision surgery.A revision surgery will need to take place.".
 
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.
 
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Brand Name
PIONEER SURGICAL TECHNOLOGY STREAMLINE MIS PEDICLE SCREW
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
PIONEER SURGICAL TECHNOLOGY
357 river park circle
marquette MI 49855
Manufacturer (Section G)
PIONEER SURGICAL TECHNOLOGY
357 river park circle
marquette MI 49855
Manufacturer Contact
gina calcaterra
357 river park circle
marquette, MI 49855
9062269909
MDR Report Key13894125
MDR Text Key289875568
Report Number1833824-2022-00026
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K222493
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 05/01/2024
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received03/24/2022
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 Received03/21/2024
Was Device Evaluated by Manufacturer? No
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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