MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	6968439
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nausea (1970); Seizures (2063); Swelling (2091); Vomiting (2144); Abdominal Distention (2601)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient began to experience adverse events post-op that led to an extended hospital stay before release.Once discharged the patient continued to experience issues, and contacted nuvasive to determine what the materials are made from.The patient stated to have unconfirmed sulfur, nickel and silver allergies."contraindications include, but are not limited to: infection, local to the operative site, signs of local inflammation.Patients with known sensitivity to the materials implanted." "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, metal sensitivity, or allergic reaction to a foreign body" "warning: this device contains nickel.Do not implant in patients with known, or suspected nickel sensitivity." device remains in-situ.
Event or Problem Description
On tuesday, (b)(6) 2020, a patient underwent an anterior lumbar interbody fusion, and suffered a seizer in the recovery room.The following day the patient started experiencing bloating, intense vomiting and nausea.As a result the patient was not released from the hospital for three days.After being released from the hospital the patient began to experience pain, a distended stomach, swelling of her leg joints, as well as intermittent right leg collapse.The issues have led to multiple er visits.

• Brand Name: NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 10826524
• Report Number: 2031966-2020-00202
• Device Sequence Number: 17063924
• Product Code: KWQ
• UDI-Device Identifier: 00887517965745
• UDI-Public: 887517965745
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

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: 6968439
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR