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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Intraoperative Pain (2662)

Event Date 08/28/2018

Event Type  malfunction  

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 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
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: daniel nelson ; 375 river park circle; marquette, MI 49855 ; 9062264489
• MDR Report Key: 9415603
• MDR Text Key: 219787774
• Report Number: 1833824-2018-00032
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00846468052362
• UDI-Public: (01)00846468052362(10)289680
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 130286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR