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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC. FLAREHAWK INTERBODY FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE
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INTEGRITY IMPLANTS INC. FLAREHAWK INTERBODY FUSION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
Model Number II-1-0120/II-1-0108
Health Effect - Clinical Code No Code Available (3191)
Date of Event 01/19/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported during follow-up that a patient was presenting with radicular symptoms.It was determined (by the surgeon) via x-ray that a shim had migrated posteriorly and did not appear locked.The initial procedure was performed at l5-s1 and it was noted that the shim may not have been locked.A revision was accomplished several weeks later in which the surgeon removed the shim and not the shell.The shell was left in the disc space and surrounded and filled with bone graft.The removed shim was not returned to the manufacturer to review for a defect.
 
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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 Key7262610
Report Number3012797630-2017-00001
Device Sequence Number11218315
Product Code MAX
UDI-Device Identifier00850231007107
UDI-Public(01)00850231007107(10)0006C/(01)00850231007022(10)SM1333
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
K160076
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
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 NumberII-1-0120/II-1-0108
Device Catalogue NumberFHTA-CS-00-27A/FHTA-S1-00-27A
Device Lot Number0006C/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 01/19/2017
Initial Report FDA Received Date02/11/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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