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

Model Number	II-1-0455/II-1-0412
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/04/2019
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.During the revision surgery the surgeon removed the shim, but the shell component was not removed.Since the shell was stable and intervertebral height was being maintained, the surgeon left the shell in the disc space and filled it with additional graft.This shim was returned to the manufacturer and no defects were observed.Post-operative imaging from the original procedure indicated that the shim component was not locked into the shell component as indicated in the surgical technique.

• Brand Name: FLAREHAWK INTERBODY FUSION SYSTEM
• Common Device Name: LUMBAR INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• MDR Report Key: 8465842
• Report Number: 3012797630-2019-00001
• Device Sequence Number: 1341050
• Product Code: MAX
• UDI-Device Identifier: 00818613020625
• UDI-Public: (01)00818613020625(10)SM2411/(01)00818613020694(10)SM2257
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K160076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 03/29/2019

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: II-1-0455/II-1-0412
• Device Catalogue Number: FHTA-CT-00-27-B2/FHTAS30627S
• Device Lot Number: SM2411/SM2257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/29/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR