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

Model Number 05-PA-55

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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 pre surgalign reported that "issue: 3 screws experienced pre-mature breakage at the proximal ring during procedure.2 of the in-situ breakages occurred when reduction load was being applied through them using the proximal threads with the threaded reduction tools.3rd breakage occurred at one end of the construct.A salvage technique was attempted, but the screws had to be removed and replaced.This troubleshooting added about 90 minutes to the procedure.Threaded reducer component part numbers: (04-reduce-ins-hndl, 05-thrdreducer, 04-thrdred-handle, 04-rdsetscr-ins) 05-pa-45-xx and 05-pa-55-xx pedicle screws experienced issues".

• 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 Key: 17289951
• MDR Text Key: 318854401
• Report Number: 1833824-2023-00085
• 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: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 05-PA-55
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other