MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGY, INC DBA RTI SURGICAL PIONEER SURGICAL STREAMLINE TL SET SCREW

Model Number 01-SETSCREW

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 08/21/2018

Event Type  Injury  

Manufacturer Narrative

The implant was returned and passed all inspection criteria.A device history review was completed and the implant was manufactured to the defined specifications.Inspections are still ongoing.

Event Description

During a revision surgery for an unrelated concern it was identified that posterior spinal rod locking set screws loosened.A locking set screw was replaced and the remaining locking set screws were tightened.

• Brand Name: PIONEER SURGICAL STREAMLINE TL SET SCREW
• Type of Device: SET SCREW
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY, INC DBA RTI SURGICAL; 375 river part circle; marquette 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY D.B.A. RTI SURGICAL; 375 river park circle; marquette MI 49855
• Manufacturer Contact: daniel nelson ; 375 river park circle; marquette, MI 49855 ; 9062269909
• MDR Report Key: 7898955
• MDR Text Key: 121047731
• Report Number: 1833824-2018-00031
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00846468006143
• UDI-Public: (01)00846468006143(10)295261
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140696
• 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: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 01-SETSCREW
• Device Catalogue Number: SAME
• Device Lot Number: 295261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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