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

Model Number 01-PA-65-45

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 11/10/2022

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 " patient recovery - original surgery was l4-5, ls5-s1 on (b)(6) 2022.Intervention occurred (b)(6) 2022 to redo the foraminotomy bilaterally at l4-5 and onth left at l5-s1.Patient is now 6 months post revision and reports: he is doing much better and feels like things have improved, only complaint is about numbness in his left foot.Off all pain medications and is not taking anything related to his back.".

• Brand Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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
• Manufacturer Contact: lyndsey rivord ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 17162080
• MDR Text Key: 317506916
• Report Number: 1833824-2023-00061
• 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: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01-PA-65-45
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other