MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC, PALM BEACH GARDENS, FL FLAREHAWK INTERBODY FUSION SYSTEM; SHELL, SHORT 25 MM, FLAREHAWK 9

Model Number	ASY-00034
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 accelus was informed of a complaint on a flarehawk9 implant.The original surgery was a plif at l3/l4 and took place on (b)(6) 2021.It was reported that during a follow up visit it was confirmed under radiographic imaging that the entire construct had migrated out of the level.As a result, a revision surgery was performed on (b)(6)2022 to remove the migrated construct.The level was then filled with allograft and the procedure was completed without complication.No additional patient harm was reported.The removed construct was discarded at the hospital and not available for return.

• Brand Name: FLAREHAWK INTERBODY FUSION SYSTEM
• Common Device Name: SHELL, SHORT 25 MM, FLAREHAWK 9
• Manufacturer (Section D): INTEGRITY IMPLANTS INC, PALM BEACH GARDENS, FL; integrity implants inc; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer (Section G): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer Contact: rod atkins ; 354 hiatt drive; palm beach gardens, FL 33418 ; 5615064996
• MDR Report Key: 13793639
• Report Number: 3012797630-2022-00011
• Device Sequence Number: 13868317
• Product Code: MAX
• UDI-Device Identifier: 00810004723474
• UDI-Public: (01)00810004723474(10)10190013
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K182114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 03/15/2022

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: ASY-00034
• Device Catalogue Number: FHPACS0023SB
• Device Lot Number: 10190013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CAT: FHPAS10023X, LOT: 10190041
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female