MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE® COROENT® THORACOLUMBAR SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation (2001); Bowel Perforation (2668)

Event Date 08/03/2018

Event Type  Death  

Manufacturer Narrative

No product has been returned for evaluation nor were xrays provided to confirm the alleged event.Labeling: ".As with any major surgical procedures, there are risks involved in orthopedic surgery.Rarely, some complications may be fatal." ".Potential risks identified with the use of this system, which may require additional surgery, include: death.".

Event Description

On (b)(6) 2018 patient underwent an extreme lateral interbody fusion procedure.Reportedly, patient suffered complications related to a bowel perforation and passed away several days post-surgery.At this time, there is no product malfunction reported or allegation that nuvasive product contributed to alleged event.

• Brand Name: NUVASIVE® COROENT® THORACOLUMBAR SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: yobana sanchez ; 7475 lusk blvd; san diego, CA 92121 ; 8589093383
• MDR Report Key: 7837450
• MDR Text Key: 118906636
• Report Number: 2031966-2018-00138
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K170962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR