MAUDE Adverse Event Report: NUVASIVE INC. COALESCE THORACOLUMBAR INTERBODY FUSION SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	4090288P2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned to nuvasive and no radiographs provided so the complaint was unable to be confirmed.The patients postoperative physical activity or if a fall was experience is unknown.Review of the reported event noted that two weeks after index placement an interbody migrated back into the right foramen for which no root cause could be determined however, implant selection and placement, space preparation, insufficient fixation and or excessive postoperative physical activity are suspected as the cause or contributors to the event.No additional investigation can be completed.Manufacturing review: no lot code information was provided so a complete manufacturing review could not be completed.Although review of ncmr records and similar events notes no non-conformance's with respect to material type, treatments or dimensions that may have caused or contributed to this mode of failure.Labeling review: "potential adverse events and complications potential adverse effects resulting from use of the coalesce thoracolumbar interbody fusion system include, but are not limited to, the following: loosening, cracking or fracture of the implant components.Loss of fixation in bone." "warnings and precautions.The coalesce thoracolumbar interbody fusion system should be used only by those physicians who have been trained in the appropriate, specialized procedures.Knowledge of appropriate surgical techniques, instrumentation, proper selection and placement of implants and postoperative patient care and management are essential to a successful outcome.Correct selection of the coalesce thoracolumbar interbody fusion system implant components is extremely important.Carefully select the appropriate device size based on the needs of each individual patient.Always handle the coalesce thoracolumbar interbody fusion system components carefully.The surface of the implant must be protected from damage during handling.Avoid contacting the implant with other tools or materials that could notch, scratch or otherwise damage the implant surface.Damage to the implant¿s surface finish may result in loss of proper mechanical function of the device." "patient selection information the surgeon is responsible for patient selection.The surgeon is responsible for understanding the appropriate indications and contraindications associated with the device and selecting the surgical procedures and techniques determined to be the best for each individual patient.Each surgeon must evaluate the appropriateness of the device and the procedure used to implant the device based on his/her own training experience.The physician must determine if the device is appropriate for patients having any of the following physical or emotional conditions: drug and/or alcohol and/or tobacco addiction and/or abuse.Infectious disease.Malignancy.Local bone tumors.Systemic or metabolic disorders.Compromised wound healing.Obesity.Demonstrated psychological instability, inappropriate motivation or attitude.Unwillingness to accept the possibility of multiple surgeries for revision or replacement.Lack of understanding that their preoperative capacity may not be fully recovered even after successful implantation." "information to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at." 9402597-en g-2022-06.
Event or Problem Description
The event was identified during a review of the pmcf interbody study, the report identified that on (b)(6) 2024 a patient underwent a transforaminal lumbar interbody fusion procedure at l4/5.On (b)(6) 2024, x-rays demonstrate that the interbody has migrated from the disc space back into the right foramen.On (b)(6) 2024, a l4-5 tlif revision took place with no additional information provided.

• Brand Name: COALESCE THORACOLUMBAR INTERBODY FUSION SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer Contact: whitney ginter ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 20489135
• Report Number: 2031966-2024-00275
• Device Sequence Number: 17024036
• Product Code: MAX
• UDI-Device Identifier: 00887517056399
• UDI-Public: 887517056399
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K203714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/19/2024

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: 4090288P2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 70 YR
• Patient Sex: Male