MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC FLAREHAWK INTERBODY FUSION SYSTEM SHELL, SHORT 29MM, FLAREHAWK9; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	ASY-00044
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The reported event was unable to be confirmed due to limited information received from the customer.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.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 unknown reasons approximately six (6) weeks later.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.

• Brand Name: FLAREHAWK INTERBODY FUSION SYSTEM SHELL, SHORT 29MM, 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: 11484705
• Report Number: 3012797630-2021-00009
• Device Sequence Number: 19686206
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: ASY-00044
• Device Catalogue Number: FHTACS0027SB
• Device Lot Number: 04190113
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/28/2020
• 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: SHIM, 12MM X 29MM, 6 DEGREE, FHTAS30627X, 11190001
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR