MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC FLAREHAWK INTERBODY FUSION SYSTEM SHELL, SHORT 27MM, SPLIT SHIM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	II-1-0454
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The reported event was confirmed by review of x-rays provided.The device history record was reviewed, and no discrepancies were found.A review of the complaint history determined that no further action was required as no trends were identified.Root cause was unable to be determined with the information provided.There are warnings in the package insert that this type of event can occur, and risks are addressed in risk documentation.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Integrity implants will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent an initial fixation procedure.Subsequently, the patient underwent a revision procedure due to posterior migration of the entire construct approximately two years later.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: FLAREHAWK INTERBODY FUSION SYSTEM SHELL, SHORT 27MM, SPLIT SHIM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• MDR Report Key: 11484826
• Report Number: 3012797630-2021-00010
• Device Sequence Number: 3412418
• Product Code: MAX
• UDI-Device Identifier: 00818613020618
• UDI-Public: (01)00818613020618(10)SM2177
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2021

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-1-0454
• Device Catalogue Number: FHTA-CS-00-27-B2
• Device Lot Number: SM2177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPLT SHIM, 10MM X 27MM, 6 DEG, FHTAS10627S, SM2252
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR