MAUDE Adverse Event Report: CENTINEL SPINE, INC. PRODISC C; PROSTHESIS, INTERVERTEBRAL DISC

Device Problems Collapse (1099); Loose or Intermittent Connection (1371)

Patient Problems Dysphagia/ Odynophagia (1815); Dyspnea (1816); Failure of Implant (1924); Pain (1994); Dysphasia (2195); Neck Pain (2433)

Event Date 09/01/2018

Event Type  Injury  

Event Description

Caller reported prodic-c cervical prosthesis (by depuy / johnson and johnson, now acquired by centinel spine inc.) was implanted in (b)(6) 2013 to treat injury post car accident in (b)(6) 2012.In (b)(6) 2018, caller began to experience difficulty breathing, dyspnea, difficulty swallowing leading to inability to eat, airway obstruction, and pain.In (b)(6) of 2018, caller's mri revealed the implant was collapsed due to loose placement and implant failure causing posterior neck damage.(b)(6) 2018 the caller had the device removed and replaced with a plate and screw system to stabilize and realign neck.Caller is still experiencing pain and difficulty speaking; lost his job, insurance, and nearly went bankrupt.A class action lawsuit was filed but did not include his serial number.He called johnson & johnson to gather info, but instead was sent letters asking for the device to be sent back to their facility.Caller is still in possession of the device.He then sought legal advice from a lawyer who informed him legal action was not advisable as he would lose the case due to liability laws that favor johnson & johnson.

• Brand Name: PRODISC C
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, INC.
• MDR Report Key: 8798131
• MDR Text Key: 151429834
• Report Number: MW5088189
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR