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

Model Number 5485555

Device Problem Loss of Osseointegration (2408)

Patient Problem Failure of Implant (1924)

Event Date 01/21/2011

Event Type  malfunction  

Event Description

A lateral interbody implant containing 2 interfixated bone screws was inserted in the l4-l5 disc space on (b)(6) 2010.There was no supplemental fixation added posteriorly at that time.4-month post-op plain film dated (b)(6) 2011 showed the l5 (inferior) screw had begun backing out of the interbody implant and a moderate amount of implant subsidence was also noted.6 month follow-up films on (b)(6) 2011 showed additional screw backout and interbody subsidence.On (b)(6) 2014 the pt presented with right groin pain, at which point plain film depicted the inferior screw had further backed out of the interbody device.Revision surgery was performed on (b)(6) 2014, during which the screw was removed and unilateral pedicle screws were added.The removed lateral screw was discarded by the user facility.

Manufacturer Narrative

(b)(4).Per the surgeon, the pt has reported a complete resolution of pain and lower extremity weakness post-revision surgery.No permanent impairment or injury occurred.The device was discarded by the hosp and has not been returned for failure investigation.No additional eval has been possible.No supplemental fixation was added during the initial surgery in (b)(6) 2010.This lateral interbody device is not intended to be used for standalone spinal fixation.See scanned page.

• Brand Name: NUVASIVE COROENT SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA
• Manufacturer Contact: brett greenwald ; 7475 lusk blvd; san diego, CA 92121 ; 8583205252
• MDR Report Key: 4095067
• MDR Text Key: 19298856
• Report Number: 2031966-2014-00051
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5485555
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/09/2014
• Event Location: Home
• Date Manufacturer Received: 07/01/2014
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 101