MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) PIONEER SURGICAL STREAMLINE TL LOCKING SET SCREW; LOCKING SCREW

Model Number 01-SETSCREW

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Intraoperative Pain (2662)

Event Date 01/23/2017

Event Type  Injury  

Manufacturer Narrative

The explanted devices were returned and after examination, it was determined that they were all within specifications.However, the wear marks on the spinal rods and the set screws give evidence that two of the set screws were not locked down into the spinal construct.It is unknown as to why the user did not lock these set screws down.The surgical technique for this system defines the proper technique for final locking of the set screws.

Event Description

In the country of (b)(6), it was discovered after the initial surgery for a posterior spinal fusion that 2 of the locking set screws had come loose.A revision surgery took place to remove the set screws along with two of the bone screws and the spinal rods.These were replaced and surgery was completed successfully.

• Brand Name: PIONEER SURGICAL STREAMLINE TL LOCKING SET SCREW
• Type of Device: LOCKING 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: 6350557
• MDR Text Key: 68083380
• Report Number: 1833824-2017-00004
• 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: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 01-SETSCREW
• Device Catalogue Number: SAME
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 01/PA-65-45; 10-55-PR-100
• Patient Outcome(s): Required Intervention