MAUDE Adverse Event Report: 3 ENTERPRISE DR #210 SPINE WAVE; SNIPER PEDICLE SCREW SYSTEM

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 06/13/2017

Event Type  malfunction  

Event Description

A screw was inserted while attached to screw inserter that consists of two parts.When it was disconnected from the extension, part of the extension at the distal end broke off.This happened two times.The.

• Brand Name: SPINE WAVE
• Type of Device: SNIPER PEDICLE SCREW SYSTEM
• Manufacturer (Section D): 3 ENTERPRISE DR #210
• MDR Report Key: 6707721
• MDR Text Key: 79933465
• Report Number: 6707721
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 98