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

Model Number 7803115

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

Patient Problems Dysphagia/ Odynophagia (1815); Failure of Implant (1924)

Event Date 05/22/2015

Event Type  malfunction  

Event Description

Initial three level acdf was performed on (b)(6) 2014 to fuse c3-c6 vertebral bodies.During a follow up visit; 05/22/2015, the patient complained of dysphagia and it was noted that the left caudal bone screw at c6 had back out from the plate.Revision surgery was performed on (b)(6) 2015, and the bone screw was removed and replaced.The remaining hardware (plate and screws) were left in-situ.The patient is reportedly doing well post revision surgery.Patient's activity level, compliance with post-surgical instructions or if the patient sustained some impact or fall are unknown.

Manufacturer Narrative

(b)(4).No radiographs were received confirming the event.Though the screw was removed and replaced, the hospital will not relinquish the dev ice at this time.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.Patient fusion rate is unknown.The device was placed for 12 months.If healing is delayed, or does not occur, the implant may eventually loosen, bend or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant.The root cause of this reported even has not been determined; no conclusion can be drawn.See scanned page.

• Brand Name: NUVASIVE HELIX- R-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: 4850477
• MDR Text Key: 20125652
• Report Number: 2031966-2015-00031
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093804
• 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: 06/12/2015

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: 7803115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2015
• 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
• Patient Outcome(s): Required Intervention