MAUDE Adverse Event Report: NUVASIVE, INC. BRIGADE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	6941438
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while impacting the implant within the disc space via inserter and mallet, the implant fractured.It was reported that proper surgical technique was followed.A new implant was used to successfully complete the procedure and there was no adverse impact to the patient, user, or procedure.No additional information is available.
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the reporter.No device was returned to nuvasive for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/technique.A review of manufacturing records was unable to be performed as the lot information of the product involved in the event was not available.A definitive root cause was unable to be determined with the information provided.".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.".".Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.".".Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.".".Care should be used in the handling and storage of the brigade implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.".If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: BRIGADE
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 17176710
• Report Number: 2031966-2023-00132
• Device Sequence Number: 12464690
• Product Code: MQP
• UDI-Device Identifier: 00887517398741
• UDI-Public: 887517398741
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K100043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6941438
• 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: 05/24/2023
• Initial Report FDA Received Date: 06/21/2023
• 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: BRIGADE INSERTER,UNKNOWN MALLET.
• Patient Sex: Prefer Not To Disclose