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

Model Number 6791714

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 11/01/2014

Event Type  malfunction  

Event Description

The initial single level acdf surgery date was late november.On (b)(6) 2014, it was reported that one of the cranial, cervical bone screw fractured and was immediately noted post operatively on the exit radiographs.Pt is asymptomatic and the surgeon elected to continue to monitor the pt.The interbody and the screws remain in-situ.No plan for revision surgery.

Manufacturer Narrative

(b)(4).The bone screw remains in the pt and has not been returned, and no further evaluation of the product can be completed at this time.Pt's bone quality or level osteosclerotic bone is unk, but could have contributed to the intra-operative stress fracture of the bone screw during placement.The root cause of this reported event has not been determined; no conclusion can be drawn.Labeling review notes the following: "potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.".

• Brand Name: NUVASIVE COROENT INTERLOCK SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE, CERVICAL
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA
• Manufacturer Contact: peter perhach ; 7475 lusk blvd.; san diego, CA 92121 ; 8589093347
• MDR Report Key: 4438929
• MDR Text Key: 5386980
• Report Number: 2031966-2014-00090
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102547
• 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: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6791714
• 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: 12/19/2014
• 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