MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE COROENT LC SYSTEM INTERVERTEBRAL BODY FUSION DEVICE

Model Number COROENT LC, 8X11X25

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2012

Event Type  Other  

Event Description

The intervertebral body device reportedly was placed during a tlif procedure at l4-l5 disc space. The surgery was completed and upon review of post operative ct scan it was decided that the placement was too posterior into the vertebral canal with the canal potentially being compromised. Revision surgery was completed the following day.

Manufacturer Narrative

(b)(4). Coroent lc, 8x11x25 8 degrees reportedly was placed during a l4-l5 tlif on friday august 31, 2012. Later in the evening the ct scan revealed that the implant was placed posterior into the vertebral canal with potentially compromising the vertebral canal. Ct scans were not made available to nuvasive. The surgeon brought the pt back the following day and decided to remove the implant and surgically widened the decompression and mitigated the need for a coroent implant. There was no pt injury and no related symptoms as a result of the placement or removal of this implant. The tlif surgical technique relies on identifying anatomical landmarks for successful placement of a coroent lc implant. It appears the surgeon was unsuccessful in his surgical technique and was unable to identify the final placement before concluding treatment of the pt. This resulted in the need for revision surgery the following day. There was no alleged product deficiency reported with this event.

• Brand Name: NUVASIVE COROENT LC SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA
• Manufacturer Contact: paul holbrook ; 7475 lusk blvd; san diego, CA 92121 ; 8583205285
• MDR Report Key: 2755748
• MDR Text Key: 3005095
• Report Number: 2031966-2012-00044
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K081611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/17/2012,09/14/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/14/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: COROENT LC, 8X11X25
• Device Catalogue Number: 6608125
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/04/2012
• 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 TREATMENT DATA

Date Received: 09/14/2012 Patient Sequence Number: 1