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 12/19/2014

Event Type  malfunction  

Event Description

During a routine 2 week follow up on a single level acdf surgery, it was noted that two of the cervical bone screws fractured cranially.The interbody and bone screws remain in-situ.Pt is asymptomatic and will continued to be monitored.No plan for revision surgery.Pt's activity level, compliance with post-surgical instructions and bone integrity are unk.

Manufacturer Narrative

(b)(4).The screw remains in the pt and has not been returned, and no further eval of the product can be completed at this time.It is unk if the pt sustained a fall or other impact.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." "loads on the device produced by load bearing and by the pt's activity level will dictate the longevity of the implant".

• 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: 4438938
• MDR Text Key: 5386982
• Report Number: 2031966-2014-00091
• 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