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

Model Number 7680365

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

Patient Problems Failure of Implant (1924); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Following implantation of disc prostheses at the c5-c6 spine levels on (b)(6) 2014, the artificial disc was reported to have migrated.Device at the c6 level was removed and replaced with fusion and stabilization implants on (b)(6) 2014.No injury occurred.

Manufacturer Narrative

Nuvasive reference (b)(4).The reported event is confirmed at the c5-c6 level; the inferior plate has been displaced anteriorly.The device has been returned and analysis is pending.No root cause has been identified.Review of the dhr indicates all material types, dimensions and treatments wee within specification at the time of release.

• Brand Name: PCM CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTABRAL DISC
• Manufacturer (Section D): NUVASIVE, INC.; san diego CA
• Manufacturer Contact: paul holbrook ; 7475 lusk blvd; san diego, CA 92121 ; 8583205285
• MDR Report Key: 3891689
• MDR Text Key: 4425947
• Report Number: 2031966-2014-00003
• 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: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7680365
• Device Lot Number: SV8211
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 8 MO
• Event Location: Hospital
• Date Manufacturer Received: 01/09/2014
• Date Device Manufactured: 06/06/2013
• 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