MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE ACP SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	18009234
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Headache (1880); Rash (2033); Neck Pain (2433); Swelling/ Edema (4577)
Date of Event	05/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was returned to nuvasive for evaluation as it is still in-situ, no lab reports or images were provided so the complaint could not be confirmed.Review of the reported event and conversation with the patient identified the patient is having an allergic reaction to implanted materials postoperative of anterior cervical discectomy and fusion that included nuvasive and two other manufacturers products, she was just tested and found to be severely allergic to nickle.Manufacturing review identified there is no nickle utilized in the manufacturing of the nuvasive implants used in her case.No additional investigation is required at this time.Labeling review: "description the nuvasive acp system is an anterior cervical plating system that consists of a variety of implant components including screws and plates, as well as associated manual general surgical instruments.The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.The subject device components are manufactured from titanium alloy (ti-6al-4v eli) conforming to astm f136 or iso 5832-3." "contraindications use of the nuvasive acp 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.Potential risks identified with the use of this system, which may require additional surgery, include, metal sensitivity or allergic reaction to a foreign body." "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.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." "post-operative warnings during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques." h3 other text: still in-situ.
Event or Problem Description
On (b)(6) 2023, a female patient underwent an anterior cervical interbody fusion at c5 to c7 including an acp plate and screws, 2 peek spacers from another manufacturer as well as autograft without issue, however several days after the procedure the patient started experiencing a reaction.(body aches, pain and swelling, head aches, sick to stomach) post reaction allergy testing identified a sever reaction to nickle.The patient is working with her surgeon and allergist on a plan but wants to know the materials involved in her products.

• Brand Name: NUVASIVE ACP 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: geoffery gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 18847328
• Report Number: 2031966-2024-00072
• Device Sequence Number: 7702423
• Product Code: KWQ
• UDI-Device Identifier: 00195377008756
• UDI-Public: 195377008756
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2024

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: 18009234
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 03/06/2024
• 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: 18008313 SCREWS.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female