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

Model Number UNKNOWN

Device Problem Disassembly (1168)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device remains in the patient so therefore no lot number could be identified.No manufacturing records could be inspected nor could the device involved.The surgeon has no plans on revising this patient.

Event Description

It was reported that a posterior lumbar pedicle screw has come apart post operatively.The surgeon has no plans on revising at this time.No more information is known about this case.

• Brand Name: PIONEER SURGICAL STREAMLINE MIS PEDICLE SCREW
• Type of Device: BONE 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: 7278005
• MDR Text Key: 100477257
• Report Number: 1833824-2018-00004
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130286
• 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: 02/16/2018

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
• 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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1