MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC FLAREHAWK INTERBODY FUSION SYSTEM BONE FUNNEL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	II-1-0431
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
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.The recovered shell and shim construct, bone funnel, and tamp were returned to integrity implants for evaluation.There was no evidence of damage present on the implants or the instrumentation.All devices were conforming to specifications.Investigation results concluded that the reported event was due to deviation from the surgical technique.There are warnings in the surgical technique manual to refrain from using a mallet to advance the graft, as this type of event can occur.A summary of the investigation has been 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 one-level transforaminal lumbar interbody fusion procedure.During the procedure, after the implanted devices had been placed and expanded, the surgeon proceeded to fill the space with autologous bone graft.While implanting the graft, the surgeon attempted to use a mallet to drive the graft down the funnel.In doing so, the force to the funnel impacted the interbody construct and resulted in migration of the construct into the retroperitoneal space, where it could not be retrieved.A new interbody construct was successfully placed, filled, and the posterior incision was closed.Subsequently, general surgery assisted in removal of the construct anteriorly.The additional surgical approach resulted in a procedural delay of approximately one hour.No additional patient consequences were reported.

• Brand Name: FLAREHAWK INTERBODY FUSION SYSTEM BONE FUNNEL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• MDR Report Key: 11435421
• Report Number: 3012797630-2021-00005
• Device Sequence Number: 19655108
• Product Code: LXH
• UDI-Device Identifier: 00818613020250
• UDI-Public: (01)00818613020250(10)2630
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/08/2021

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: II-1-0431
• Device Catalogue Number: II-1-0431
• Device Lot Number: 2630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/08/2021
• 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: BONE TAMP, II-1-0435, 2630; FH9 10MM X 29MM 6DEG SHIM, FHTAS10627X, 10100059; FH9 29MM SHORT SHELL, FHTACS0027SB, 10190016
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR