MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC FLAREHAWK INTERBODY FUSION SYSTEM SHIM, 11MM OR 13MM X 25MM, 6 DEGREE, FH9; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	CMP-00114
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2020
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.Investigation results concluded that the reported event was due to incomplete locking of the implant components during the initial implantation.The results of the investigation were communicated to the complainant conveying proper surgical technique and use of the device.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 transforaminal lumbar interbody fusion procedure.Subsequently, the patient underwent a revision procedure due to posterior migration of the inner component from the implanted construct approximately seven (7) weeks later.Information provided by the representative confirmed that the construct was not locked during the initial implantation but was retained due to patient anatomical reasons.No additional patient consequences were reported.

• Brand Name: FLAREHAWK INTERBODY FUSION SYSTEM SHIM, 11MM OR 13MM X 25MM, 6 DEGREE, FH9
• 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: 11484766
• Report Number: 3012797630-2021-00008
• Device Sequence Number: 11616046
• Product Code: MAX
• UDI-Device Identifier: 00810004723542
• UDI-Public: (01)00810004723542(10)10190039
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K182114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: CMP-00114
• Device Catalogue Number: FHPAS20623X
• Device Lot Number: 10190039
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2020
• 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: SHELL, SHORT 25MM, FH9, FHPACS0023SB, 10190007
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR