MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL STREAMLINE TL SPINAL FIXATION; SETSCREW, STREAMLINE SCREW SYSTEM

Model Number	01-SETSCREW
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After continued requests for further information on the patient and the initial surgical date, there was no more information able to be gathered.Device was returned and a dhr review was completed and it was found to be manufactured to pioneer surgical's specifications.An inspection of the returned device revealed that there were witness marks only on one side of the set screw surface that comes in contact with the spinal rod.The most likely probable cause of this is that the rod was not fully seated within the pedicle screw prior to locking down the set screw.In the surgical technique for this product, there is a caution statement reminding the surgeon to ensure correct rod bending and placement and risks of improper bending and placement that may inhibit proper locking.
Event or Problem Description
It was reported that a patient had to have a revision surgery on (b)(6) 2019 due to a set screw backing out.The revision surgery was completed.

• Brand Name: PIONEER SURGICAL STREAMLINE TL SPINAL FIXATION
• Common Device Name: SETSCREW, STREAMLINE SCREW SYSTEM
• Manufacturer (Section D): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 9255244
• Report Number: 1833824-2019-00030
• Device Sequence Number: 2054383
• Product Code: NKB
• UDI-Device Identifier: 00846468006143
• UDI-Public: (01)00846468006143(10)336180
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 01-SETSCREW
• Device Catalogue Number: SAME
• Device Lot Number: 336180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/30/2019
• 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