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

Model Number	6050823P2
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Laceration(s) (1946); Damage to Ligament(s) (1952)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product was received as the involved device currently remains in situ with no plans for revision at this time.No radiographs could be provided confirming alleged incident.The root cause of the event is a device use error as it was reported that there was perforation to the patients anterior longitudinal ligament with the bone filled cage which was implanted resulting in device malplacement.No additional investigation required.Label review: ".Potential adverse events and complications - as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries." ".Potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury." ".Warnings, cautions and precautions: 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." ".Pre-operative warnings - 5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".
Event or Problem Description
On a (b)(6) 2022 a patient underwent a posterior lateral interbody fusion procedure on the lumbar region of the spine.During the procedure while inserting the spacer cage in-between l5-sacrum the cage fell ventrally.It was reported that a contributor was perforation of the anterior longitudinal ligament by grafted bone filled in the cage.At the time the surgeon determined retrieval of the cage would be unsafe and left the malplaced implant in-situ.The surgery was completed final tightening.Ct scan showed no change in the cage position and no adverse effects were determined, it was decided to leave the cage in situ and the patient will be monitored.

• Brand Name: NUVASIVE THORACOLUMBAR INTERBODY SYSTEMS: NUVASIVE COROENT THORACOLUMBAR SYSTEM,
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 14023908
• Report Number: 2031966-2022-00073
• Device Sequence Number: 19494685
• Product Code: MAX
• UDI-Device Identifier: 00887517722652
• UDI-Public: 887517722652
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2022

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: 6050823P2
• 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: 03/09/2022
• Initial Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female