MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC. FLAREHAWK TIHAWK 9 INTERBODY FUSION DEVICE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	FHTAS100299S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023 accelus was informed of a revision surgery to remove an unlocked flarehawk 9 shim from a tihawk 9 implanted cage.The initial surgery took place on (b)(6) 2023.It was later reported that the shim was unlocked and migrating from the shell.During the revision procedure on (b)(6) 2023, the surgeon made incision on left side of patient and dissected down to the l5-s1 posterior joint on left side of patient.Retraction of the tissue was performed over left side l5-s1.The surgeon then removed the shim with the use of pituitaries.The surgeon was advised by vincent frazier (sales rep) to remove the shell per the surgical technique manual; however, they chose to leave the shell in place at l5-s1.In-depth assessment of exiting nerve roots and spinal were done, the procedure was then completed without issue.Reportedly, the patient was not experiencing any symptoms as a result of the migrated shim.No additional patient harm was reported during the revision surgery.

• Brand Name: FLAREHAWK TIHAWK 9 INTERBODY FUSION DEVICE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): INTEGRITY IMPLANTS INC.; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer (Section G): INTEGRITY IMPLANTS INC.; 354 hiatt dr; palm beach gardens FL 33418
• Manufacturer Contact: lauren kamer ; 354 hiatt drive; palm beach gardens, FL 33418 ; 5615293861
• MDR Report Key: 18007440
• Report Number: 3012797630-2023-00005
• Device Sequence Number: 7582410
• Product Code: MAX
• UDI-Device Identifier: 00810045530499
• UDI-Public: (01)00810045530499(10)02210262
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K202198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/25/2023

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: Health Professional
• Device Model Number: FHTAS100299S
• Device Catalogue Number: FHTAS100299S
• Device Lot Number: 02210262
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White