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

Model Number 01-SETSCREW

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Intraoperative Pain (2662)

Event Type  Injury  

Manufacturer Narrative

A full investigation could not be performed since the device was not returned for evaluation and after repeated attempts no information could be gathered about the patient, surgeries or the hospital.Device not returned.

Event Description

It was discovered in the country of austria that a posterior spinal rod set screw came loose approximately 6 weeks post operatively.The patient was revised and the set screw was removed and replaced.No other information is available at this time.

• Brand Name: PIONEER SURGICAL TECHNOLOGY STREAMLINE TL SYSTEM, SET SCREW
• Type of Device: SPINAL ROD SET 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: 6660455
• MDR Text Key: 78177304
• Report Number: 1833824-2017-00018
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K140696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• 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: 01-SETSCREW
• Device Catalogue Number: SAME
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention