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

Model Number 6851010

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/03/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, a (b)(6) year old female underwent a tlif procedure using an intervertebral fusion device.While being placed into the disc space, the device was unintentionally passed beyond the annulus.It dislocated from the inserter and became lodged in the retroperitoneal space.A second device placement was attempted but was also unsuccessful.The surgeon was not able to retrieve either device from the pt.A vascular surgeon was consulted and an aortogram and venogram were performed to ensure the spacers were not impinging on any vessels.The studies determined the spacers were not presenting any immediate harm.The pt is asymptomatic.The placement of the cage may necessitate a revision surgery.The revision surgery date is unk.

Manufacturer Narrative

Nuvasive ref.# (b)(4).No radiographs confirming the event have been received.The devices remain in situ and have not been returned for eval.The inserter has not been released by the hospital and cannot be evaluated.No further investigation of the devices can be performed at this time.The root cause of this reported event has not been determined; no conclusion can be drawn.

• Brand Name: INTERVERBRAL FUSION DEVICE
• Type of Device: COROENT SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA
• Manufacturer Contact: kim mccaleb ; 7475 lusk blvd.; san diego, CA 92121 ; 8589091980
• MDR Report Key: 4349532
• MDR Text Key: 5172516
• Report Number: 2031966-2014-00084
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6851010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: No
• 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: 49 YR
• Patient Weight: 64