MAUDE Adverse Event Report: NUVASIVE NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Model Number	7805535
Medical Device Problem Codes	Fracture (1260); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for investigation nor were x-rays provided to confirm the alleged event.Labeling review: potential adverse events and complications ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s); loss of fixation; nonunion or delayed union." post-operative warnings: '.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.".
Event or Problem Description
As per reporter 10 days post index procedure two broken screws were noted.No revision procedure was not performed.
Additional Manufacturer Narrative
No product has been returned for evaluation as no product malfunction was alleged.Review of additional information identified the patient has undergone six surgical procedures since initial screw placement.The broken screw was revised in (b)(6) of 2017 where a non-fusion was identified.No patient bone quality results available.It is unknown if the patient followed post operative physical restrictions.The root cause of the reported fracture is thought to be the result of patient related factors and a known inherent risk of device.No further investigation can be completed.
Event or Problem Description
Additional information received from patient stating patient was experiencing pain and underwent a reconstructive procedure at l4 and l5, s1 where the bone growth material did not take.It is unknown when the revision procedure occurred.

• Brand Name: NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
• Common Device Name: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 9505453
• Report Number: 2031966-2019-00265
• Device Sequence Number: 1189313
• Product Code: KWQ
• UDI-Device Identifier: 00887517162670
• UDI-Public: 887517162670
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2020

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: 7805535
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 84