MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC FLAREHAWK INTERBODY FUSION DEVICE; INERBODY FUSION DEVICE

Model Number	FHPACS0025TT
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During a case on 1/27 that, heather cain, was attending, it was reported that dr.(b)(6) was performing an mis l4-s1 tlif on a 36 year old female patient.He placed a metrix retractor at l5 s1 and performed a discectomy at that level using rounded shavers and other disc prep instruments made by depuy-synthes.He utilized a 6mm, 8mm, 9mm, and 10mm sharp shaver in the disc space and requested the shortest entry profile implant (7mm h) to get a 14mm high.It was advised that we recommend line-to-line sizing with the implant.He requested the 14mm.The surgeon then asked for bone graft, it was advised that bone graft can interfere with the nose expansion of the implant.The surgeon continued with prepacking of the cancellous chips bone graft material.The tech proceeded to load the requested implant.Upon insertion in to the disc space the implant would not lock out and then the removal procedure had to be done with flarehawk removal instruments to remove the implant.It was advised using a shorter implant.The dr requested the tall shell with a 14mm implant.This implant would also not lock out and had to be removed using the same process, he attempted this 2 more times each time removing the implant.(total 4 sets of shims and shells removed) each time it was advised that our recommendation is line to line sizing with our shavers.He then asked for the shorter implant (still 14mm high).This implant was put in the disc space and it would not lock out.The final time we were only able to remove the shim, the surgeon decided to leave the shell at l5/s1 to prevent any further risk with the removal procedure.The procedure was completed by leaving a fh9 short shell in place at l5/s1.At l4/l5 the surgeon sized up to a 10mm shaver and placed a 10mm 6-degree implant without further incident.It was reported there was a 60 min delay to the surgery for insertion and removal of the additional implants.No patient impact was reported.Surgical technique was not utilized for oversizing of the implant relative to the shaver size and prepacking bone graft.

• Brand Name: FLAREHAWK INTERBODY FUSION DEVICE
• Common Device Name: INERBODY FUSION DEVICE
• Manufacturer (Section D): 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: chris mckee ; 354 hiatt drive; palm beach gardens, FL 33418 ; 5615293861
• MDR Report Key: 21427198
• Report Number: 3012797630-2025-00005
• Device Sequence Number: 8189664
• Product Code: MAX
• UDI-Device Identifier: 00810004728158
• UDI-Public: (01)00810004728158
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/20/2025

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: FHPACS0025TT
• Device Catalogue Number: FHPACS0025TT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/20/2025
• 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
• Patient Age: 26 YR
• Patient Sex: Female