MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGIES THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM; 6.5MM X 50MM STREAMLINE PEDICLE SCREW

Model Number 01-PA-65-50

Device Problem Insufficient Information (3190)

Patient Problem Paresthesia (4421)

Event Date 06/20/2022

Event Type  Injury  

Event Description

Our distribution partner surgalign reported the surgeon "saw that the pedicle was broken in the caudal part by the screw compromising the exiting l5 root.We removed the l5 screw, reviewed the root, and maintained the rest of the screws and the rods".Also "the patient cannot dorsiflex his left foot, after surgery.".

Manufacturer Narrative

The device remains in patient and is not available for investigation.A dhr review was not conducted as the batch number is unknown.This report will be updated should this information become available at a later date.

• Brand Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Type of Device: 6.5MM X 50MM STREAMLINE PEDICLE SCREW
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGIES; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNONLOGY; 375 river park circle; marquette 49855
• Manufacturer Contact: lyndsey rivord ; 375 river park circle; marquette, MI 49855
• MDR Report Key: 15249244
• MDR Text Key: 298131424
• Report Number: 1833824-2022-00070
• 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: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01-PA-65-50
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization