MAUDE Adverse Event Report: LIFE SPINE, INC. IRIS ANTERIOR CERVICAL PLATE SYSTEM

Model Number	418-022
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Immediate post-op, films were not available to determine if the screw was locked down at implantation.Device not returned to company.
Event or Problem Description
Cervical bone screw backed out of plate.

• Brand Name: IRIS ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s quality dr.; huntley IL 60142
• MDR Report Key: 5821075
• Report Number: 3004499989-2016-00004
• Device Sequence Number: 814781
• Product Code: KWQ
• UDI-Device Identifier: 00190837004293
• UDI-Public: 00190837004293
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K130202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2016

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: 418-022
• Device Catalogue Number: 418-022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2016
• Initial Report FDA Received Date: 07/25/2016
• 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: 55 YR