MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 13X15 H5 US; MOBI-C CERVICAL DISC PROTHESIS

Catalog Number MB3355

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myalgia (2238); Neck Pain (2433); Neuralgia (4413)

Event Type  Injury  

Manufacturer Narrative

H6 additional patient code: 4836.Without a product return, no product evaluation is able to be conducted.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

A patient reported a successful mobi-c surgery to address radiating nerve pain in their left arm caused by the disc at c5/6.However the patient states they are having worsening arm, neck, and back muscle and nerve pain that radiates down both arms.There are currently no plans for a revision surgery.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 13X15 H5 US
• Type of Device: MOBI-C CERVICAL DISC PROTHESIS
• Manufacturer (Section D): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 18730728
• MDR Text Key: 335703387
• Report Number: 3004788213-2024-00012
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110009
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MB3355
• Device Lot Number: 5377009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• 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
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic