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

Model Number 7680365

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

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Event Description

Prosthesis was implanted (b)(6) 2013 in the c5-c6 disc space.Three months later the device was determined to have migrated anteriorly sufficiently to require removal of the device on (b)(6) 2014.No injury is known to have occurred.

Manufacturer Narrative

(b)(4).The reported event has been confirmed via radiograph.The implant began shifting shortly after placement.Evaluation of the explanted product is in process.No root cause has been identified.Review of the dhr for the lot indicates all specifications have been met.

• 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: 3757342
• MDR Text Key: 4548416
• Report Number: 2031966-2014-00015
• 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: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• 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: SV8070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2013
• 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