MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	16017540
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)
Date of Event	03/30/2024
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2024 a spinal procedure was conducted at t10/l4.It is noted the blood pressure dropped interoperatively with no medical device malfunction or bleeding.On (b)(6) 2024 the patient died, but it was not reported to the rep until (b)(6) 2024.The physician commented that the patient had an infection prior to surgery and that anesthesia may have been the cause of death.
Additional Manufacturer Narrative
No product was returned as no product malfunction was alleged.No radiographs or images or lab reports were provided so the complaint cannot be confirmed.Review of the reported event identified an infection was present prior to surgery.The physician commented anesthesia may have been the cause of the event.The root cause cannot be determined although allergic reaction to anesthesia and previous patient infection prior to surgery may be the cause or contributor to the event.No additional investigation can be completed, if additional information is provided another report will be filed.Labeling review: "contraindications include, but are not limited to: 1.Infection, local to the operative site.2.Signs of local inflammation.6.Patients with physical or medical conditions that would prohibit beneficial surgical outcome." "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 include: early or late infection.Rarely, some complications may be fatal.Potential risks identified with the use of this system, which may require additional surgery, include:.Metal sensitivity or allergic reaction to a foreign body, infection.Death." "pre-operative warnings 1.Only patients that meet the criteria described in the indications should be selected.2.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." 9401879-en p-12/2018 h3 other text : device in-situ.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 19130287
• Report Number: 2031966-2024-00113
• Device Sequence Number: 6853472
• Product Code: NKB
• UDI-Device Identifier: 00887517553935
• UDI-Public: 887517553935
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K223181
• 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): 04/17/2024

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: 16017540
• 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: 04/08/2024
• Initial Report FDA Received Date: 04/18/2024
• 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: RELINE POSTERIOR FIXATION CONSTRUCT
• Outcome Attributed to Adverse Event: Death
• Patient Age: 70 YR
• Patient Sex: Male