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

Model Number 01-PA-65-40

Device Problem Insufficient Information (3190)

Event Date 04/26/2023

Event Type  Injury  

Event Description

Our distribution partner surgalign reported that "radiolucency is observed in screw l4.Tac is indicated to determine if there is mobility of the screw.".Possible pseudarthrosis.

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.No additional information or confirmation has been given that this is a pioneer surgical technologies manufactured part.

• Brand Name: PIONEER SURGICAL TECHNOLOGY
• 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 ; 9062269909
• MDR Report Key: 16952527
• MDR Text Key: 315454335
• Report Number: 1833824-2023-00030
• 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: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-PA-65-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other