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

Model Number	05-PA-75-40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The explanted screws were not returned to rti surgical for evaluation.A dhr review was conducted and confirmed that this device met manufacturing specification prior to shipping from rti surgical.
Event or Problem Description
It was reported to rti surgical on (b)(6) 2020 that two streamline mis pedicle screws broke "months after surgery".The screws were discovered to be broken on (b)(6) 2019.Index and revision surgery dates are unknown.

• 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
• MDR Report Key: 10082670
• Report Number: 1833824-2020-00023
• Device Sequence Number: 11472103
• Product Code: NKB
• UDI-Device Identifier: 00846468052515
• UDI-Public: (01)00846468052515(10)334927
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K130286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2020

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-75-40
• Device Catalogue Number: SAME
• Device Lot Number: 334927
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 05/22/2020
• 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: Hospitalization