MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/21/2023

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.The following sections of this report have been left blank due to the information being unavailable or non-applicable:.

Event Description

Our distribution partner surgalign reported that "status post l3 to s1 fusion with likely pseudoarthrosis at l5-s1.".

• 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 MI 49855
• Manufacturer Contact: lyndsey rivord ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 17130887
• MDR Text Key: 317205444
• Report Number: 1833824-2023-00041
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other