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

Device Problem Disassembly (1168)

Patient Problem Intraoperative Pain (2662)

Event Date 05/25/2017

Event Type  Injury  

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 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
• Type of Device: SPINAL FIXATION SCREW
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL); 375 river park circle; marquette MI 49855
• Manufacturer Contact: dan nelson ; 375 river park circle; marquette, MI 49855 ; 9062264489
• MDR Report Key: 6661057
• MDR Text Key: 78181125
• Report Number: 1833824-2017-00019
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00846468052362
• UDI-Public: (01)00846468052362(10)252393
• 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: Other
• Type of Report: Initial
• Report Date: 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• 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: 73 YR