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

Model Number 7739217

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

Patient Problem Failure of Implant (1924)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

The initial two level acdf was performed on (b)(6) 2014 to fuse c3-c5 vertebral bodies.During a follow up visit it was noted that the caudal bone screw at c5 had separated from the plate and was noted to be deeply embedded in the vertebral body.Revision surgery was performed on (b)(6) 2015 and the bone screw was easily removed and replaced.The patient is reportedly doing well post revision surgery.Patient's activity level, compliance with post-surgical instructions and bone integrity are unknown.

Manufacturer Narrative

(b)(4).Radiographs received confirmed the event.Evaluation of the returned bone screw displays distortion of the washing collapsed upon the head of the screw.The washer condition is a result of the screw and washer passing through the plate.Review of the device history records notes no material non-conformance's or manufacturing errors that may have caused or contributed to this mode of failure.The depth of the bone screw in the vertebral body was unusual.It is unknown if the depth was a result of initial placement or post-operative separation.Patient impact/sustained fall, poor bone quality or other factors contributing to a failure are 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: 4550828
• MDR Text Key: 15895386
• Report Number: 2031966-2015-00003
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 7739217
• Device Lot Number: NM1711
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2013
• 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