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

Model Number	148-003
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned unable to complete a full analysis.
Event or Problem Description
It was reported 1 month post operatively, following surgery that set screw came out of the right l5 pedicle.

• Brand Name: LIFE SPINE
• Common Device Name: AVATAR
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s. quality drive; huntley IL 60142
• MDR Report Key: 8428112
• Report Number: 3004499989-2019-00002
• Device Sequence Number: 13508481
• Product Code: NKB
• UDI-Device Identifier: 00190837000943
• UDI-Public: 00190837000943
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2019

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
• Operator of Device: Health Professional
• Device Model Number: 148-003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR