MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) RTI SURGICAL STREAMLINE MIS 06.5MM X 40MM DL MIS PEDICLE SCREW ASSY

Model Number	05-PA-65-40
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Intraoperative Pain (2662)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to rti surgical and the components that were able to be inspected were within specifications.A dhr review was completed and the device was manufactured to rti specifications.
Event or Problem Description
Rti attempted to submit this initial report to the fda on (b)(6) 2018.It has recently come to our attention that this report did not go through the electronic submission completely and does not show up on the maude database.For this reason, rti surgical is resubmitting this initial report.The initial complaint "it was reported by a rep that a screw had disassociated post-operatively and as a result a revision surgery was done.".

• Brand Name: RTI SURGICAL STREAMLINE MIS 06.5MM X 40MM DL MIS PEDICLE SCREW ASSY
• 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: 9415603
• Report Number: 1833824-2018-00032
• Device Sequence Number: 19445663
• Product Code: NKB
• UDI-Device Identifier: 00846468052362
• UDI-Public: (01)00846468052362(10)289680
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: 130286
• 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): 12/05/2019

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-65-40
• Device Catalogue Number: N/A
• Device Lot Number: 289680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 12/05/2019
• 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: 65 YR