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

Model Number 7160845P2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation as product remains in-situ nor were radiographs provided to confirm the alleged event.No allegation of product malfunction.Labeling review: potential adverse events and complications- ".Potential risks identified with the use of this system, which may require additional surgery, include: fracture of the vertebra." no product returned.

Event Description

On (b)(6) 2018, patient underwent an extreme lateral interbody fusion procedure at l2-l5 levels.A post-operative ct image reveled a fracture on the iliac bone and at the l4 level vertebral body.As per reporter it unknown if index procedure may have caused or contributed to alleged event.On (b)(6), patient underwent a planned posterior spinal fusion procedure at t10-s2a1 and a posterior lumbar inter body fusion at l5/6/s1 levels.Alleged fractures were not addressed.

• Brand Name: NUVASIVE® COROENT® THORACOLUMBAR SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: yobana sanchez ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 8070971
• MDR Text Key: 127143127
• Report Number: 2031966-2018-00166
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 00887517730770
• UDI-Public: 887517730770
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7160845P2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/29/2018
• Initial Date FDA Received: 11/14/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR