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
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	Intraoperative Pain (2662)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 6.5MM X 45MM STREAMLINE PEDICLE SCREW
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette MI 49855
• MDR Report Key: 7557894
• Report Number: 1833824-2018-00018
• Device Sequence Number: 1818175
• Product Code: NKB
• UDI-Device Identifier: 00846468005658
• UDI-Public: (01)00846468005658(10)208669
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention