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

Model Number	5271300P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received concerning this event.No device was returned to nuvasive for evaluation; further, no bloodwork, operative notes and/or radiograph images were provided for review.No information was made available on whether any other devices or products were implanted or placed in the patient's body.At this time, the causal relationship between nuvasive implants and the patient's reported allergic reaction is unknown and a definitive root cause is unable to be determined with the information provided.Labeling review: ".The nuvasive coroent thoracolumbar system is manufactured from.Commercially pure titanium (cp ti) conforming to astm f1580, ti6al-4v eli conforming to astm f136/ iso 5832-3, ti-6al-4v conforming to astm f1472." ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: metal sensitivity or allergic reaction to a foreign body." ".Warnings, cautions and precautions: patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery.Caution must be taken due to potential patient sensitivity to materials.Do not implant in patients with known or suspected sensitivity to the aforementioned materials." ".Contraindications: contraindications include, but are not limited to: 3.Patients with known sensitivity to the materials implanted." ".Pre-operative warnings: only patients that meet the criteria described in the indications should be selected.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that the patient underwent an initial posterior fixation procedure on an unknown date.The patient reported no allergic reaction in relation to the initial fixation.The patient then underwent a second procedure to implant an interbody and additional posterior fixation.Subsequently, it was noted that the patient experienced an allergic reaction approximately seven (7) weeks later and was being treated by another department.Information regarding the type of allergy, symptoms, or other implanted materials was requested but was not available.

• Brand Name: NUVASIVE COROENT THORACOLUMBAR SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 16406217
• Report Number: 2031966-2023-00028
• Device Sequence Number: 20423957
• Product Code: MAX
• UDI-Device Identifier: 00887517909138
• UDI-Public: 887517909138
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170962
• 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): 02/20/2023

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 Expiration Date: 12/01/2024
• Device Model Number: 5271300P2
• Device Catalogue Number: N/A
• Device Lot Number: ML3664
• 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: 01/27/2023
• Initial Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RELINE FIXATION SYSTEM.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose