MAUDE Adverse Event Report: RTI SURGICAL RTI SURGICAL STREAMLINE TL SET SCREW; STREAMLINE SET SCREW

Model Number 01-SETSCREW

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

Device history review was completed and the implant met all specifications.Several attempts have been made to get the original surgical date with no success.The patient is recovering.

Event Description

It was discovered at a post-op appointment that the screw was backing out.The patient was not in pain.The surgeon revised the patient on (b)(6) 2018.Patient is recovering.

• Brand Name: RTI SURGICAL STREAMLINE TL SET SCREW
• Type of Device: STREAMLINE SET 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: 7645105
• MDR Text Key: 112559934
• Report Number: 1833824-2018-00026
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00846468006143
• UDI-Public: (01)00846468006143(10)298476
• 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: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 01-SETSCREW
• Device Catalogue Number: SAME
• Device Lot Number: 298476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2017
• 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