MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL STREAMLINE MIS SYSTEM; PEDICLE SCREW

Model Number 05-PA-65-40

Device Problem Separation Problem (4043)

Patient Problem Insufficient Information (4580)

Event Date 02/27/2021

Event Type  malfunction  

Manufacturer Narrative

As of the date of this report the device remains implanted in the patient.A dhr review could not be conducted as the lot number is unknown.This report will be updated should additional data or the device become available at a later date.

Event Description

It was reported to rti surgical on (b)(6) 2021 that a streamline mis pedicle screw was found to be disassociated through immediate post-op imaging.The surgeon opted not to remove.

• Brand Name: PIONEER SURGICAL STREAMLINE MIS SYSTEM
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: daniel nelson ; 375 river park circle; marquette, MI 49855 ; 9062269909
• MDR Report Key: 11852178
• MDR Text Key: 262449957
• Report Number: 1833824-2021-00038
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130286
• 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: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 05-PA-65-40
• Device Catalogue Number: SAME
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• 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
• Removal/Correction Number: N/A
• Patient Sequence Number: 1