MAUDE Adverse Event Report: LIFE SPINE, INC. LIFE SPINE; AVATAR

Model Number 148-003

Device Problem Osseointegration Problem (3003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2019

Event Type  malfunction  

Manufacturer Narrative

Device was not returned unable to complete a full analysis.

Event Description

It was reported 1 month post operatively, following surgery that set screw came out of the right l5 pedicle.

• Brand Name: LIFE SPINE
• Type of Device: AVATAR
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s. quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE, INC.; 13951 s. quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 s. quality drive; huntley, IL 60142
• MDR Report Key: 8428112
• MDR Text Key: 139231332
• Report Number: 3004499989-2019-00002
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00190837000943
• UDI-Public: 00190837000943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 148-003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR