MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE CAMBER LAMINOPLASTY SYSTEM; ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Model Number	8370013P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vertebral Fracture (4520)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) a patient underwent a cervical fusion procedure from c4-c6.During the procedure the hinge side of the c6 bone was fractured when the camber plate was placed at c6.It is unknown whether the patient was experiencing any additional adverse consequences as a result of the vertebral fracture.It is unknow what was done to treat/address the vertebral fracture.
Additional Manufacturer Narrative
No device was returned as no product problem was alleged, no radiographs or images provided so the complaint could not be confirmed.The patients bone quality is unknown.Review of the reported event noted no device malfunction took place but rather the vertebral body fractured when the plate was placed indicating, an excessive hinge cut removed too much bone, insufficient bone quality and or excessive force applied during placement resulting in vertebral fracture and suggesting surgical technique as the likely cause or contributor.A review of the manufacturing history found no material nonconformance, no manufacturing error, nor discrepancies with respect to material type, treatments or dimension that may have caused or contributed to this event.Parts met acceptance criteria upon release.No additional investigation can be completed at this time.No additional investigation can be completed at this time.Label review: "potential adverse events and complications - as with any major surgical procedures, there are risks involved in 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: fracture of the vertebra "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." "method of use - please refer to the surgical technique for this device." "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 +1-800-475-9131.You may also email: info@nuvasive.Com.".

• Brand Name: NUVASIVE CAMBER LAMINOPLASTY SYSTEM
• Common Device Name: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: patrick yrigoyen ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 20057555
• Report Number: 2031966-2024-00211
• Device Sequence Number: 20912406
• Product Code: NQW
• UDI-Device Identifier: 00887517995704
• UDI-Public: 887517995704
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/23/2024

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: 8370013P
• Device Lot Number: ML03744
• 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: 07/22/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2023
• 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: Other
• Patient Age: 76 YR
• Patient Sex: Female