MAUDE Adverse Event Report: RTI SURGICAL RTI SURGICAL STREAMLINE TL SPINAL FIXATION; SETSCREW, STREAMLINE SCREW SYSTEM

Model Number	01-SETSCREW
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to rti surgical.A dhr review was conducted and confirmed that this device met manufacturing specifications prior to shipping.The screws all passed thread profile specifications.
Event or Problem Description
Patient presented with post operative pain and it was noticed through xray that the screws had loosened and a rod was shifted out of place.A revision surgery was performed on (b)(6) 2018 to replace the rods and screws.

• Brand Name: RTI SURGICAL STREAMLINE TL SPINAL FIXATION
• Common Device Name: SETSCREW, STREAMLINE SCREW SYSTEM
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette MI 49855
• MDR Report Key: 7953350
• Report Number: 1833824-2018-00033
• Device Sequence Number: 13740841
• Product Code: NKB
• UDI-Device Identifier: 00846468006143
• UDI-Public: (01)00846468006143(10)312362
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 01-SETSCREW
• Device Catalogue Number: N/A
• Device Lot Number: 312362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 10/10/2018
• 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
• Patient Age: 41 YR