MAUDE Adverse Event Report: NUVASIVE COROENT SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Model Number 6210160

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Stenosis (2263)

Event Date 08/01/2013

Event Type  malfunction  

Event Description

The patient reported on (b)(6) 2014 that following diagnosis with spinal stenosis and spondylolisthesis in the l3-l5 segments, initial surgery occurred (b)(6) 2013.Follow-up films approximately 3-weeks post-op noted the interbody device had shifted (direction unknown).Patient was asymptomatic throughout.No injury occurred.Revision was reportedly performed on (b)(6) 2014.

Manufacturer Narrative

Nuvasive reference (b)(4).The report was confirmed via radiograph; the event has been associated with the spontaneous rupture of a spinous ligament that may have precipitated the event.Revision surgery consisted of removal of the l4-l5 interbody device and replacement with an inter-fixated interbody device for additional stability.The patient reported he was asymptomatic throughout and no additional morbidity was associated with this event.No product has been returned for analysis.Root cause appears to be related to patient factors.

• Brand Name: NUVASIVE COROENT SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer Contact: paul holbrook ; 7475 lusk blvd; san diego, CA 92121 ; 8583205285
• MDR Report Key: 4230288
• MDR Text Key: 4974827
• Report Number: 2031966-2014-00075
• 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: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6210160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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 Age: 72 YR