MAUDE Adverse Event Report: RTI SURGICAL RTI SURGICAL STREAMLINE TL PEDICLE SCREW; 6.5MM X 45MM STREAMLINE PEDICLE SCREW

Model Number 01-PA-65-45

Device Problem Disassembly (1168)

Patient Problem Intraoperative Pain (2662)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

A device history review was conducted and the implant passed all specifications prior to being shipped.Complaint device was returned and inspected.The cause of the issue has not been able to be determined at this time.Further evaluation is being done and if cause is determined we will update this report with the results.

Event Description

A posterior spinal fusion surgery was performed on the patient on (b)(6) 2018.Patient started to have pain a few weeks after this initial surgery.A ct scan was completed for this patient and the scan showed that the pedicle screw head disassembled.The patient was revised on (b)(6) 2018 and the disassembled screw was removed and replaced.

• Brand Name: RTI SURGICAL STREAMLINE TL PEDICLE SCREW
• Type of Device: 6.5MM X 45MM STREAMLINE PEDICLE SCREW
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): RTI SURGICAL; 375 river park circle; marquette MI 49855
• Manufacturer Contact: daniel nelson ; 375 river park circle; marquette, MI 49855 ; 9062264489
• MDR Report Key: 7557894
• MDR Text Key: 109706351
• Report Number: 1833824-2018-00018
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00846468005658
• UDI-Public: (01)00846468005658(10)208669
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 01-PA-65-45
• Device Catalogue Number: SAME
• Device Lot Number: 208669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2015
• 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