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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

As of the date of this report, it is unknown if revision surgery has taken place.A dhr review could not be conducted as the lot number is unknown.This report will be updated should the device or additional information become available at a later date.

Event Description

It was reported to rti surgical on (b)(6) 2021 that a streamline mis pedicle screw tulip disassociated post-operatively.This took place in italy.The index surgery was performed approximately in late april or early (b)(6) 2021.It is unknown at this time if revision surgery will be performed.

• Brand Name: PIONEER SURGICAL STREAMLINE MIS SYSTEM
• 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: daniel nelson ; 375 river park circle; marquette, MI 49855 ; 9062269909
• MDR Report Key: 12092830
• MDR Text Key: 263208597
• Report Number: 1833824-2021-00042
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K13028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other