MAUDE Adverse Event Report: NUVASIVE MONOLITH

Model Number	5992537
Health Effect - Clinical Codes	Failure of Implant (1924); Ambulation or Postural Difficulties (2544)
Date of Event	06/28/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Device-related failure of modular (stackable) monolith (b)(4) procode mqp resulting in serious neurocompromise rendering patient paralyzed following single-level c6 anterior cervical corpectomy and fusion (accf).Patient required posterior revision surgery post-op six months and is relearning to walk again.The monolith device was explicitly cleared for use below the neck in the thoracolumbar spine, but is in lordotic cage geometry and design rationale intended for use in the cervical spine and cannot possibly be used for its labeled purpose.Device component part numbers include: 5991220, 5991153, 5992537.

• Brand Name: MONOLITH
• Common Device Name: MONOLITH
• Manufacturer (Section D): NUVASIVE
• MDR Report Key: 6728303
• Report Number: MW5071101
• Device Sequence Number: 1371925
• Product Code: MQP
• UDI-Device Identifier: 00887517677365
• UDI-Public: 00887517677365
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2017
• 3 Devices were Involved in the Event: 1 2 3

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: 5992537
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention; Disability
• Patient Age: 52 YR
• Patient Weight: 95