MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC FLAREHAWK INTERBODY FUSION SYSTEM SHIM, 8MM OR 11MM X 29MM, 0 DEGREE, FLAREHAWK9; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	CMP-00166
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It is unknown if product will be returning to integrity implants and 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 posterior lumbar interbody fusion procedure.Subsequently, post-operative imaging identified posterior migration of the inner component from the implanted construct approximately seven weeks later.The patient has not undergone a revision at this time, as the surgeon intends to monitor the patient to determine if a revision would be necessary.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4).No revision surgery has been reported to integrity implants at the time of this report.No patient consequences were reported.The dhr review did not identify any potential issues with the device history records that may have contributed to the reported event.A review of the complaint history determined that no further action was required as no trends were identified.A root cause was unable to be determined as it is unknown if the component failure was identified intra-operatively.Through multiple communication attempts, we have been unable to confirm if a revision surgery occurred.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 posterior lumbar interbody fusion procedure.Subsequently, post-operative imaging identified posterior migration of the inner component from the implanted construct approximately seven weeks later.The patient has not undergone a revision at this time, as the surgeon intends to monitor the patient to determine if a revision would be necessary.No patient consequences were reported.

• Brand Name: FLAREHAWK INTERBODY FUSION SYSTEM SHIM, 8MM OR 11MM X 29MM, 0 DEGREE, FLAREHAWK9
• 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: 11272256
• Report Number: 3012797630-2021-00003
• Device Sequence Number: 3440889
• Product Code: MAX
• UDI-Device Identifier: 00810004723597
• UDI-Public: (01)00810004723597(10)12190060
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2021

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: CMP-00166
• Device Catalogue Number: FHTAS10027X
• Device Lot Number: 12190060
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 07/22/2021
• 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: FH9 SHELL, LORDOTIC 29MM, FHTACT0927H, 10190012.; FH9 SHELL, LORDOTIC 29MM, FHTACT0927H, 10190012.
• Patient Age: 51 YR