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

Device Problem Use of Device Problem (1670)

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

Our distribution partner (b)(4) reported that "as per reporter, patient was undergoing a revision procedure of a streamline mis.The surgeon was having a difficult time removing the set screws and ended up breaking the tip off of one of the set screw starters (which he shouldn't have been using) but he was frustrated so he was grabbing anything he could out of the instrument tray.He also broke the tip off of one of the "simple drivers" i believe (i was not at the case and am hearing second hand) trying to get a screw out.No patient harm, a slight delay in case but overall everything came out.Index surgery date was (b)(6) 2021".

• Brand Name: PIONEER SURGICAL TECHNOLOGY
• 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 49855
• Manufacturer Contact: lyndsey rivord ; 375 river park circle; marquette, MI 49855 ; 9062269909
• MDR Report Key: 16631720
• MDR Text Key: 312412808
• Report Number: 1833824-2023-00026
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192396
• 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: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2023
• 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