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

Model Number 01-RS-C-75-35

Device Problem Disassembly (1168)

Patient Problem Intraoperative Pain (2662)

Event Date 12/21/2017

Event Type  Injury  

Manufacturer Narrative

Since the pedicle screw was not returned there was no evaluation of the actual device performed.Since the lot number and part number were not made available by the user of this device there was no dhr review.No further information was available for this occurrence.

Event Description

It was reported to pioneer surgical that a patient needed to be revised due to a pedicle screw that had disassembled sometime after the initial surgery in (b)(6) 2016.The patient was revised on (b)(6) 2017.

• Brand Name: PIONEER SURGICAL (D.B.A. RTI SURGICAL) STREAMLINE TL PEDICLE SCREW SYSTEM
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: dan nelson ; 375 river park circle; marquette, MI 49855 ; 9062264489
• MDR Report Key: 7205423
• MDR Text Key: 97731535
• Report Number: 1833824-2018-00001
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 01-RS-C-75-35
• Device Catalogue Number: SAME
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2017
• 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): Required Intervention