MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE COROENT SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	6980850
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation.Image provided confirmed the complaint.No lot information provided so manufacture review could not be completed.The reason for the revision procedure or the events that took place during are unknown.The root cause of this failure is unknown, but could possibly be the result of excessive force during removal and/or improper technique during placement.No additional investigation can be completed at this time.Labeling review: ".Potential adverse events and complications: as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".Warnings, cautions and precautions: these devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break." ".Patient education: the patient should be made aware of the limitations of the implant and potential risks of the surgery." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.
Event or Problem Description
A patient underwent an extreme lateral interbody fusion procedure on an unknown date with out a reported incident.A revision was performed by another manufacture for an unknown reason on (b)(6) 2020, where the interbody cage was removed from a patient and a titanium location pin was missing.Imaging revealed it was in the patient's left psoas muscle and would have been extremely difficult to remove.
Additional Manufacturer Narrative
No product was returned for evaluation.Image provided confirmed the complaint.Review of the reported event identified surgeons notes confirmed the cage was malplaced requiring a difficult removal process where the pin was pushed out of the cage most likely as a result of anatomical contact and excessive force.The root cause of the reported failure appears to be the result of a surgical error in placement and the excessive force required to reposition and subsequently remove it.The unretrieved fragment was left in-situ located in the left side psoas muscle where post-operative images confirmed the generation of fibrosis around it reducing the chances of later migration.No additional investigation can be completed.Labeling review: "warnings, cautions and precautions: the subject device is intended for use only as indicated.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants".Corrected or updated data found in sections: a3, b5, d6, d8, e1, e2, e3, g2, g3, g6, h2, h6, h10.
Event or Problem Description
New information provided by the legal team via the surgeon on 04/12/2021 has corrected the complaint description below: a patient underwent an extreme lateral interbody fusion procedure on (b)(6) 2020 during which a lumbar inter-body cage was malplaced to anterior requiring removal and repositioning.The interbody cage was removed from a patient and a titanium location pin was missing, a ct scan was performed and revealed the pin was in the patient's left psoas muscle and would have been extremely difficult to remove.The surgeons prerogative was to leave as is.No revision has been completed at this time.

• Brand Name: NUVASIVE COROENT SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 11164640
• Report Number: 2031966-2021-00006
• Device Sequence Number: 17073692
• Product Code: MAX
• UDI-Device Identifier: 00887517403209
• UDI-Public: 887517403209
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141665
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: 6980850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 04/12/2021
• 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: 6981050; 6981050