MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL TECHNOLOGY STREAMLINE MIS PEDICLE SCREW

Model Number UNKNOWN

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problem Intraoperative Pain (2662)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

The broken screw was not returned for evaluation.The surgical technique for this product line describes the proper use of spinal rod contouring.In this surgery the surgeon did not contour the rod, which may have led to the difficulty in locking the set screw.Requests were made for initial surgery and supporting surgical records but these have not been made available.No further information is available at this time.Device not returned for evaluation.

Event Description

On (b)(6) 2016 the patient was revised for a broken pedicle screw in a single level posterior spinal rod fusion construct.The surgeon took out the broken screw and added another level to the construct.During this process there were difficulties in locking a set screw onto the pedicle screw.This difficulty extended the surgery time.

• Brand Name: PIONEER SURGICAL TECHNOLOGY STREAMLINE MIS PEDICLE SCREW
• 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: dan nelson ; 375 river park circle; marquette, MI 49855 ; 9062264489
• MDR Report Key: 5890812
• MDR Text Key: 52734642
• Report Number: 1833824-2016-00030
• Device Sequence Number: 1
• Product Code: NKB
• 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: 08/19/2016

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?: Yes
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR