MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT "M" STANDARD 15X15 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB3XXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Inadequate Pain Relief (2388); Neck Pain (2433)

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to 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

It was reported that the patient is having radiating pain down their arm again, shoulder cramps and most symptoms from before their mobi-c surgery.The pain has never left their neck.The patient will have a myography to see what the issue may be.The patient is currently on medication and physical therapy to address pain management.

Manufacturer Narrative

Device evaluation: product not returned and photos and x-rays were not provided.Device evaluation unable to be completed.Complaint unrefuted for mobi-c implant not leading to patient improvement.Potential cause: root cause was unable to be determined.This event could possibly be attributed to unknown patient or surgical factors.Dhr review: dhr review unable to be performed as no lot information is known.Device usage: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that the patient is having radiating pain down their arm again, shoulder cramps and most symptoms from before their mobi-c surgery.The pain has never left their neck.The patient will have a myography to see what the issue may be.The patient is currently on medication and physical therapy to address pain management.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X15 H5 US
• Type of Device: MOBI-C CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16438575
• MDR Text Key: 310366935
• Report Number: 3004788213-2023-00016
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110009
• 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,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MB3XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/08/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 111 KG