MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE HELIX-T-ACP SYSTEM; SPINAL INT VERT BODY FIXATION APPLIA

Model Number 7739215

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 05/15/2015

Event Type  malfunction  

Event Description

Initial three level acdf was performed on (b)(6) 2014 to fuse c4-c7 vertebral bodies.During a follow up visit, it was noted that the bone screw at c4 had backed out from the plate.Patient is asymptomatic.Surgeon elected to continue to monitor.No revision is planned.The hardware (plate and screws) remain in-situ.Patient's activity level, compliance with post-surgical instructions or if the patient sustained some impact or fall are unknown.

Manufacturer Narrative

(b)(4).Radiograph was received confirming the event.The device remains in-situ.No product information was given, no product returned and no further evaluation of the product can be completed at this time.Patient bone quality is unknown.The root cause of this reported event has not been determined; no conclusion can be drawn.

• Brand Name: NUVASIVE HELIX-T-ACP SYSTEM
• Type of Device: SPINAL INT VERT BODY FIXATION APPLIA
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA
• Manufacturer Contact: peter perhach ; 7475 lusk blvd.; san diego, CA 92121 ; 8589093347
• MDR Report Key: 4850495
• MDR Text Key: 5811515
• Report Number: 2031966-2015-00029
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083341
• 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: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 7739215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 06/13/2015
• 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