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; in addition, an acdf was performed at c3-c4.In a f/u office visit, the patient reported feeling a sense of pressure in the throat; 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.Further evaluation of the explanted product is not possible; the product has been retained by the facility.The patient concurrently underwent an acdf procedure.No root cause has been identified.Review of the dhr for the lot indicates all specifications have been met.Labeling review: "risks associated with implants in the spine, including the pcm cervical disc device, are: early or late loosening of the components; disassembly; bending or breakage of any or all of the components; implant migration; malpositioning of the implant; loss of purchase; sizing issues with components; anatomical or technical difficulties."."the safety and effectiveness of this device has not been established in patients with the following conditions:.Fusion at an adjacent vertebral level.Similar to the experience in acdf control group, the use of the pcm cervical disc at a spinal level adjacent to a previous fusion may lead to clinical outcomes inferior to those observed for patients without a prior adjacent level fusion.For the pcm cervical disc, these include, but are not limited to, possible implant migration and higher incidence of subsequent device removal.

• 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 boulevard; san diego, CA 92121 ; 8583205285
• MDR Report Key: 3757384
• MDR Text Key: 17930106
• Report Number: 2031966-2014-00016
• 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: 03/14/2014,03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• 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: MO
• Event Location: Hospital
• Date Manufacturer Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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