MAUDE Adverse Event Report: PIONEER SURGICAL (D.B.A. RTI SURGICAL) PIONEER SURGICAL TECHNOLOGY, INC STREAMLINE OCT OCCIPTIO-CERVICO- THORACIC SYSTE; POSTERIOR CERVICAL SCREW

Model Number 26-PA-35-14

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

This report came in during a review of clinical data.To date, patient demographics have not been disclosed to rti surgical.A dhr review could not be conducted as the lot number is unknown.As of the date of this report, the screw remains implanted in the patient.This report will be updated should additional information become available at a later date.

Event Description

It was reported to rti surgical that a streamline oct screw was observed to be broken post-operatively.Index surgery date is unknown.The broken screw remains implanted and at the time of this report no revision surgery has been reported.Additional information will be added to this report should it become at a later date.

• Brand Name: PIONEER SURGICAL TECHNOLOGY, INC STREAMLINE OCT OCCIPTIO-CERVICO- THORACIC SYSTE
• Type of Device: POSTERIOR CERVICAL 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: 9741932
• MDR Text Key: 198543257
• Report Number: 1833824-2020-00016
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172139
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26-PA-35-14
• Device Catalogue Number: SAME
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2020
• 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