MAUDE Adverse Event Report: CENTINEL SPINE, LLC; SCREWDRIVER

Model Number IN436

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 07/25/2019

Event Type  malfunction  

Event Description

This is a reusable instrument for spine procedures from the spine vendor tray.Company name is centinel spine.

• Type of Device: SCREWDRIVER
• Manufacturer (Section D): CENTINEL SPINE, LLC; 900 airport rd ste 3b; west chester PA 19380
• MDR Report Key: 9179726
• MDR Text Key: 168444770
• Report Number: 9179726
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/23/2019,08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IN436
• Device Lot Number: 2016-104
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2019
• Date Report to Manufacturer: 10/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20805 DA