MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC FLAREHAWK INTERBODY FUSION SYSTEM, SHELL, LORDOTIC 25MM, FLAREHAWK 9; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	ASY-00029
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).At this time, the patient has not been revised and product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient underwent an initial lumbar interbody fusion procedure.Subsequently, post-operative imaging identified posterior migration of the inner component from the implanted construct approximately four months later.A revision of the implanted components has been scheduled, however, has not occurred at the time of this report.No additional patient consequences were reported.
Event or Problem Description
Upon reassessment of the reported event, it was determined that no serious injury occurred as was initially reported as a result of this product complaint.There was no reported surgical delay, death or serious illness or injury associated with this complaint.The initial report was submitted in error and should be voided.
Additional Manufacturer Narrative
The following sections were updated: b4, b5, g3, g6, h2, h10.Upon reassessment of the reported event, it was determined that no serious injury occurred as was initially reported as a result of this product complaint.There was no reported surgical delay, death or serious illness or injury associated with this complaint.The initial report was submitted in error and should be voided.

• Brand Name: FLAREHAWK INTERBODY FUSION SYSTEM, SHELL, LORDOTIC 25MM, FLAREHAWK 9
• 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: 11023116
• Report Number: 3012797630-2020-00005
• Device Sequence Number: 2585984
• Product Code: MAX
• UDI-Device Identifier: 00818613021264
• UDI-Public: (01)00818613021264(10)10190009
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K182114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ASY-00029
• Device Catalogue Number: FHPACT0923H
• Device Lot Number: 10190009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 07/20/2021
• 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: FHPAS20023X, PN CMP-00110, LN 04190098
• Patient Age: 44 YR