MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC FLAREHAWK INTERBODY FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number	II-1-0120/II-1-0108
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a follow-up, lateral x-ray showed that a shim appeared to be protruding several millimeters posteriorly.It was noted that during the initial procedure the shim was difficult to deliver into the shell due to possible anatomical constraints and the surgeon chose to remove the construct and use a smaller size.During the revision procedure, the shell and shim were removed and replaced with a device from another manufacturer.The removed shell and shim were not returned to the manufacturer to review for a defect.

• Brand Name: FLAREHAWK INTERBODY FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 850 parkway; jupiter FL 33477
• MDR Report Key: 7262604
• Report Number: 3012797630-2017-00002
• Device Sequence Number: 13909062
• Product Code: MAX
• UDI-Device Identifier: 00850231007107
• UDI-Public: (01)00850231007107(10)0006C/(01)00850231007022(10)SM1333
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2018

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: Physician
• Device Model Number: II-1-0120/II-1-0108
• Device Catalogue Number: FHTA-CS-00-27A/FHTA-S1-00-27A
• Device Lot Number: 0006C/SM1333
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2017
• Initial Report FDA Received Date: 02/11/2018
• 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: Hospitalization; Required Intervention