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

Model Number 01-SETSCREW

Device Problem Migration (4003)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Device inspections could not be conducted as the implant was not returned to rti surgical.A dhr review could not be conducted as the lot number remains unknown at this time.It is unknown if a revision took place or if the surgeon intends to revise.Additional information will be added to this report should it become available at a later date.

Event Description

It was reported to rti surgical that during a patient's follow-up visit it was confirmed that a streamline tl set screw had loosened post-operatively.

• Brand Name: PIONEER SURGICAL STREAMLINE TL SPINAL FIXATION
• Type of Device: SETSCREW, STREAMLINE SCREW SYSTEM
• 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: daniel nelson ; 375 river park circle; marquette, MI 49855 ; 9062264489
• MDR Report Key: 8939117
• MDR Text Key: 155842108
• Report Number: 1833824-2019-00029
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01-SETSCREW
• Device Catalogue Number: SAME
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2019
• 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): Other
• Patient Age: 43 YR