MAUDE Adverse Event Report: LIFE SPINE LIFE SPINE; SOLSTICE

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

The patient had two 3.5 x 12 solstice screw disengage on the right c3 level and the left c4.

Event Description

Two screws disengaged one in right c3 and one in left c4.

• Brand Name: LIFE SPINE
• Type of Device: SOLSTICE
• Manufacturer (Section D): LIFE SPINE; 13951 south quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE; 13951 south quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 south quality drive; huntley, IL 60142
• MDR Report Key: 6974806
• MDR Text Key: 90869633
• Report Number: 3004499989-2017-00007
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 090343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR