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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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PIONEER SURGICAL TECHNOLOGY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 01-SETSCREW
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thromboembolism (2654)
Event Date 06/01/2023
Event Type  Injury  
Manufacturer Narrative
Device was not returned to resolve surgical for inspection.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
Our oem rep surgalign reported that "presented to the er with concern for lle pain, swelling and discoloration of the leg." deep vein thrombosis.
 
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Brand Name
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Type of Device
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 Key17197621
MDR Text Key317815151
Report Number1833824-2023-00072
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192800
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 06/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number01-SETSCREW
Was Device Available for Evaluation? No
Date Manufacturer Received06/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Life Threatening; Hospitalization;
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