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

Model Number	05-PA-65-40
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Code	Intraoperative Pain (2662)
Date of Event	05/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for evaluation and was found to be disassembled.When the components were inspected, they were found to be within specifications.Another screw of this lot was tested and the complaint failure mode could not be duplicated.The dhr was reviewed and the device was manufactured to pioneer surgical's specifications.
Event or Problem Description
The patient had a posterior spinal rod fixation surgery on (b)(6) 2017.Approximately 2 weeks post op, the patient came in for a follow up visit and it was found that one of the pedicle screws had disassociated.The patient was revised and the screw was replaced.

• Brand Name: PIONEER SURGICAL TECHNOLOGY STREAMLINE TL PEDICLE SCREW
• Common Device Name: SPINAL FIXATION SCREW
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• MDR Report Key: 6661057
• Report Number: 1833824-2017-00019
• Device Sequence Number: 1539126
• Product Code: NKB
• UDI-Device Identifier: 00846468052362
• UDI-Public: (01)00846468052362(10)252393
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2017

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?: No
• Operator of Device: Physician
• Device Model Number: 05-PA-65-40
• Device Catalogue Number: SAME
• Device Lot Number: 252393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/22/2017
• 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: 73 YR