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

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

Patient Problems Pain (1994); Patient Problem/Medical Problem (2688)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

The event could not be confirmed.Radiographs were not received.It is unknown if appropriate patient positioning and identification of anatomical landmarks was performed via palpation and/or fluoroscopy prior to advancement of instrumentation.No malfunction of specific device used in the surgery has been reported by the facility's users.Labeling: "additional care should be taken at the lower levels of the lumbar spine due to the obstruction of anatomical structures, such as the iliac crest and iliac vessels, surgical access for the subject device at the levels may not be feasible.".

Event Description

On (b)(6) 2015, a male patient underwent a lumbar fusion using a lateral access approach.On (b)(6) 2015, the patient suffered abdominal pain and was transferred to another hospital.Intestine damage was detected and an emergency surgery was performed.

• Brand Name: NUVASIVE COROENT SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: kim mccaleb ; 7475 lusk blvd.; san diego, CA 92121 ; 8589091980
• MDR Report Key: 5292751
• MDR Text Key: 33381674
• Report Number: 2031966-2015-00084
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention