MAUDE Adverse Event Report: NUVASIVE INC ARCHON ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8787240
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product problem alleged and devices are still in-situ, no lab reports or images have been provided so the complaint could not be confirmed.Review of the reported event identified the patient experienced an immune response reaction post a nuvasive cervical procedure making the causal relationship between nuvasive implants and the patient's reported allergic reaction suspect.Due to a lack of information no root cause or causal relationship could be determined a list of elements included in the involved nuvasive devices was provided to the patient as requested, the event is considered the result of patient related factors.No additional investigation can be completed at this time.Manufacturing review: no lot code information was provided so a complete manufacturing review could not be completed.Although review of ncmr records and similar events notes no non-conformances with respect to material type, treatments or dimensions that may have caused or contributed to this mode of failure.Labeling review: "contraindications use of the nuvasive archon anterior cervical plate system and spinal fixation surgery are contraindicated when there was recent or local active infection near or at the site of the proposed implantation.Any conditions that preclude the possibility of fusion are relative contraindications." "potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications known to occur include.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." "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." ".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.Proper patient selection is critical to the success of the procedure.Only patients who satisfy the criteria set forth under the indications section of this document and who do not have any of the conditions set forth under the contraindications section of this document should be considered for spinal fixation surgery using the nuvasive archon anterior cervical plate system." "patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery." "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.".
Event or Problem Description
A patient of mine has developed a severe diffuse eczema of his skin and refractory demyelination since having an acdf with the following the timing of the symptom onset in the near term after the surgery would suggest that the surgery triggered his immune system.

• Brand Name: ARCHON ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: geoffrey gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 19067686
• Report Number: 2031966-2024-00100
• Device Sequence Number: 6676981
• Product Code: KWQ
• UDI-Device Identifier: 00887517201812
• UDI-Public: 887517201812
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2024

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: 8787240
• 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: 04/04/2024
• Initial Report FDA Received Date: 04/08/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male