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

Model Number	7806535
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor lot code provided as it was left in-situ.No radiographs or images were provided that confirm the alleged event.It is unknown if the patient conformed to post-operative activity restrictions.No additional investigation can be performed at this time.Labeling review: ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".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.Patients who are unwilling to restrict activities or follow medical advice." ".These devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient¿s activity level will dictate the longevity of the implant." left in-situ.
Event or Problem Description
On an unknown date a patient underwent an anterior lumbar interbody fusion procedure at l5-s1 levels.Post-operative radiographs showed a screw fracture at s1 level.The patient was fused and has is asymptomatic.No revision procedure is planned at this time.

• Brand Name: NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 8040342
• Report Number: 2031966-2018-00161
• Device Sequence Number: 11078337
• Product Code: KWQ
• UDI-Device Identifier: 00887517141804
• UDI-Public: 00887517141804
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K121837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2018

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: 7806535
• 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: 10/17/2018
• Initial Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1