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

Model Number 05-PA-75-40

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

The explanted screws were not returned to rti surgical for evaluation.A dhr review was conducted and confirmed that this device met manufacturing specification prior to shipping from rti surgical.

Event Description

It was reported to rti surgical on (b)(6) 2020 that two streamline mis pedicle screws broke "months after surgery".The screws were discovered to be broken on (b)(6) 2019.Index and revision surgery dates are unknown.

• 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
• Manufacturer (Section G): PIONEER SURGICAL (D.B.A. RTI SURGICAL); 375 river park circle; marquette, mi
• Manufacturer Contact: daniel nelson ; 375 river park circle; marquette, mi ; 2264489
• MDR Report Key: 10082670
• MDR Text Key: 194594250
• Report Number: 1833824-2020-00023
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00846468052515
• UDI-Public: (01)00846468052515(10)334927
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K130286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 05-PA-75-40
• Device Catalogue Number: SAME
• Device Lot Number: 334927
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2019
• 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): Hospitalization