MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL STREAMLINE MIS SYSTEM; PEDICLE SCREW

Model Number	05-PA-75-55
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A dhr review was conducted and confirmed that the device met manufacturing specification prior to shipping from rti surgical.The screw was not returned to rti surgical for evaluation.This report will be updated should additional information become available or should the screw be returned to rti surgical at a later date.
Event or Problem Description
It was reported to rti surgical on (b)(6) 2020 that a streamline mis pedicle screw disassociated post-operatively.Index surgery was performed on (b)(6) 2019.Revision surgery to replace the screw was performed on (b)(6) 2020.The screw is not available for evaluation.

• Brand Name: PIONEER SURGICAL STREAMLINE MIS SYSTEM
• Common Device Name: PEDICLE SCREW
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 10977765
• Report Number: 1833824-2020-00095
• Device Sequence Number: 17185773
• Product Code: NKB
• UDI-Device Identifier: 00846468052546
• UDI-Public: (01)00846468052546(10)312988
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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: 05-PA-75-55
• Device Catalogue Number: SAME
• Device Lot Number: 312988
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/09/2020
• 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: Other
• Patient Age: 54 YR