MAUDE Adverse Event Report: PIONEER SURGICAL (RTI SURGICAL) STREAMLINE MIS PEDICLE SCREW SYSTEM

Model Number 01-SETSCREW

Device Problem Detachment Of Device Component (1104)

Patient Problems Intraoperative Pain (2662); No Information (3190)

Event Date 03/24/2015

Event Type  Injury  

Event Description

Patient had a two level lumbar fusion surgery on (b)(4) 2015.On (b)(4) 2015 it was identified in a follow up visit that one of the locking set screws had come off the construct.The patient was revised on (b)(4) 2015.

Manufacturer Narrative

During the final tightening of the set screws the surgeon used the compressor.The surgical technique for this system specifically states "do not attempt to apply full locking torque to the set screw with the compressor in place.Remove the compressor and final driver, then proceed to final set screw locking." this may have prevented the set screw from receiving the correct amount of torque for final locking.These devices have not been returned for inspection.

Manufacturer Narrative

The devices have been returned for inspection.All devices were found to be within specification.After further review there were 4 set screws in the construct that appear to have not been final locked down.The correct technique for final locking of the set screws is defined in this system's surgical technique.

Event Description

Patient was revised on (b)(6) 2015.There were 4 loose setscrews found during this revision.The rods, set screws and pedicle screws were explanted and replaced successfully.

• Brand Name: STREAMLINE MIS PEDICLE SCREW SYSTEM
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): PIONEER SURGICAL (RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: dan nelson ; 375 river park circle; marquette, MI 49855 ; 9062264489
• MDR Report Key: 4904986
• MDR Text Key: 6836473
• Report Number: 1833824-2015-00008
• 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: Other,other
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-SETSCREW
• Device Catalogue Number: SAME
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 07/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 59 YR