MAUDE Adverse Event Report: NUVASIVE, INC. PCM CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number 7680265

Device Problems Failure To Adhere Or Bond (1031); Device Slipped (1584)

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646)

Event Date 12/05/2013

Event Type  malfunction  

Event Description

Prosthesis was implanted (b)(6) 2013 at the c4-c5 spine level.On (b)(6) 2013, follow-up films noted the caudal plate of the prosthesis exhibited anterior migration of approximately 5 mm.No injury has been reported.Revision surgery was expected to occur on (b)(6) 2013.

Manufacturer Narrative

(b)(4).Radiographic review notes the prosthesis was implanted at the c4-c5 spine level; the reported event is confirmed.The device has not been returned and evaluation of the device has not occurred.No root cause has been identified.Device disposition is unclear at this time.Review of the dhr indicates all material type dimension and treatments were within specification at the time of release.

• Brand Name: PCM CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA
• Manufacturer Contact: paul holbrook ; 7475 lusk blvd.; san diego, CA 92121 ; 8583205285
• MDR Report Key: 3777070
• MDR Text Key: 4445921
• Report Number: 2031966-2013-00085
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100012
• 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: 01/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7680265
• Device Lot Number: SV8201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/05/2013
• Device Age: 10 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/05/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2013
• 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