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

Model Number	II-1-0173/II-1-0164
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient underwent a revision surgery because the shim component had migrated posteriorly.It could not be confirmed whether the shim had locked during initial implantation.During the revision surgery, the surgeon removed the shim first, followed by the shell.A new device was implanted, and shim locking was confirmed using xray.The explanted shell and shim were not returned to the manufacturer to review for a defect.

• Brand Name: FLAREHAWK INTERBODY FUSION SYSTEM
• Common Device Name: LUMBAR INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 850 parkway; jupiter FL 33477
• MDR Report Key: 7399631
• Report Number: 3012797630-2018-00002
• Device Sequence Number: 16191900
• Product Code: MAX
• UDI-Device Identifier: 00850231007473
• UDI-Public: (01)00850231007473(10)SM2030/(01)00850231007404(10)00275
• Combination Product (Y/N): N
• PMA/510(K) Number: K160076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 04/05/2018

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?: Yes
• Operator of Device: Physician
• Device Model Number: II-1-0173/II-1-0164
• Device Catalogue Number: FHTACT0027B/FHTAS30027B
• Device Lot Number: SM2030/00275
• 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: 03/13/2018
• Initial Report FDA Received Date: 04/05/2018
• 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
• Patient Age: 57 YR