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

Model Number	05-PA-65-45
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dhr review was completed and the screw met rti surgical specifications.Dimensional inspection was done for the returned broken screw and all dimensions were found to be within specifications.This report is for the screw that the shaft was left in the patient.The second broken screw for this case is documented under mdr # 1833824-2019-00002.
Event or Problem Description
The surgeon was performing a revision surgery on a patient who was experiencing pain.When he tried to remove the top screw on each side of the construct it was noticed that both of the screws were broken.The doctor removed one of the broken shafts and left the other in the patient.The patient was revised successfully and the broken hardware except for the one broken shaft was removed.

• Brand Name: RTI SURGICAL STREAMLINE MIS PEDICLE SCREW
• Common Device Name: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 8241305
• Report Number: 1833824-2019-00001
• Device Sequence Number: 19192318
• Product Code: NKB
• UDI-Device Identifier: 00846468052379
• UDI-Public: (01)00846468052379(10)253842
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K130286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 05-PA-65-45
• Device Catalogue Number: SAME
• Device Lot Number: 253842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/11/2019
• 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: 83 YR