MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C CERVICAL DISC PROSTHESIS; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Dyspnea (1816); Fatigue (1849); Headache (1880); Pain (1994); Weakness (2145)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation can not be conducted.The reference and lot number are unknown; therefore the device history records and traceability can not be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

Customer complaint : mobi-c pain and discomfort post-op.As reported by a patient via (b)(6) : i am a patient but also a doctor.I had a mobi c implant surgically implanted at 2 levels, c 4-5 and c 5-6 in (b)(6) 2014.I have just been informed that i have osteolytic changes in my vertebrae on ct scan above both implants consistent with a reaction to the implants.I have been having systemic symptoms since (b)(6) including daily migraine headaches with neck pain, right arm pain, significant fatigue, shortness of breath with activity, and muscle weakness.What started in april as daily headaches has worsened until currently.I have been seeing multiple specialist for the symptoms including a headache specialist without any relief including trying botox for the daily headaches.At this time i need information from you on such reactions as well as a slug for patch testing for my immunologist.I also need information on any other testing that my immunologist should do before proceeding forward.My surgeon has stated that the implants must come out.Additional information were requested but received no response.Exact initial surgery date, reference and lot # of device are unknown.No revision confirmed.No additional information received.

• Brand Name: MOBI-C CERVICAL DISC PROSTHESIS
• Type of Device: CERVICAL DISK PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7614067
• MDR Text Key: 111486092
• Report Number: 3004788213-2018-00196
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1