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

Model Number	6050823P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Damage to Ligament(s) (1952); Foreign Body In Patient (2687)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 during surgery to insert two cages into l5/s by transforaminal lumbar interbody fusion, the first cage was inserted without problems, and while inserting the second cage, the spinal cage broke through the all (anterior longitudinal ligament).The surgeon attempted to pull it back with an inserter that resulted in the spinal cage completely pushing out anteriorly.The surgery was terminated with one cage placed and fixation with screws.The spinal cage that broke through the all and came out anteriorly will be removed later.No revision currently scheduled.
Additional Manufacturer Narrative
No device was returned as no malfunction was alleged.No radiographs were provided therefore the complaint cannot be confirmed.Review of the reported event identified malplacement by the surgeon and in attempt to correct the malpositioning the anterior longitudinal ligament was lacerated and the implant was pushed into the abdominal cavity confirmed the root cause as an inadvertent surgical error.No additional required.Labeling 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 include: damage to blood vessels, spinal cord or peripheral nerves.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 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.Care should be taken to ensure that all components are ideally fixated prior to closure.Pre-operative warnings: care should be used during surgical procedures to prevent damage to the devices and injury to the patient.

• Brand Name: 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: 15911570
• Report Number: 2031966-2022-00275
• Device Sequence Number: 2519686
• 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): 12/02/2022

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: 11/09/2022
• Initial Report FDA Received Date: 12/02/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSERTER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Male