MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C P&F US; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Pain (1994)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the an initial report about a complaint received following the annual mobi-c enhanced surveillance survey.The review of the device history records could not be done seeing that the reference number and lot# of the device are unknown.Traceability is impossible as well for the same reason.Information requests are in progress to obtain more information about the incident.Conclusion is not "availbale" yet.Not returned.

Event Description

Mobi-c p&f us: migration.Information was collected via the annual mobi-c enhanced surveillance survey: surgeon reported an event of implant migration / subsidence on a patient that was implanted with mobi-c in the past year.Patient diagnosis pre-implantation: hnp, radiculopathy.Surgeon notes, return of left arm pain, inferior implant subsided on the left side.No additional information received.

Manufacturer Narrative

The implant was not returned for evaluation, so no results are available and no conclusions can be drawn.The lot number is unknown; therefore the device history records are unable to be reviewed.

Event Description

It was reported that following surgery, the patient experienced migration of the mobi-c implant leading to the return of their left arm pain.No information regarding a planned revision surgery was provided.

• Brand Name: MOBI-C P&F US
• Type of Device: MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8106988
• MDR Text Key: 128471689
• Report Number: 3004788213-2018-00395
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: NO INFORMATION
• Device Lot Number: NO INFORMATION
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 38 YR