MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY, INC DBA RTI SURGICAL PIONEER SURGICAL STREAMLINE TL SET SCREW

Model Number	01-SETSCREW
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implant was returned and passed all inspection criteria.A device history review was completed and the implant was manufactured to the defined specifications.Inspections are still ongoing.
Event or Problem Description
During a revision surgery for an unrelated concern it was identified that posterior spinal rod locking set screws loosened.A locking set screw was replaced and the remaining locking set screws were tightened.

• Brand Name: PIONEER SURGICAL STREAMLINE TL SET SCREW
• Common Device Name: SET SCREW
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY, INC DBA RTI SURGICAL; 375 river part circle; marquette 49855
• MDR Report Key: 7898955
• Report Number: 1833824-2018-00031
• Device Sequence Number: 169920
• Product Code: NKB
• UDI-Device Identifier: 00846468006143
• UDI-Public: (01)00846468006143(10)295261
• 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 Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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: SAME
• Device Lot Number: 295261
• 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: 08/22/2018
• Initial Report FDA Received Date: 09/21/2018
• 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