MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 13X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB3375

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

Patient Problems Pain (1994); Disability (2371)

Event Date 03/01/2020

Event Type  Injury  

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 a revision was performed to remove a mobi-c device because of post-operative pain and disability.There are no reports of device malfunction associated with this event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.H6 evaluation codes (component, investigation, findings, conclusions).The complaint is unrefuted for one mobi-c implant for the failure of revision surgery due to pain.Medical records were not provided for review.Device evaluation: product was not returned, so a device evaluation could not be performed.Potential cause root cause was unable to be determined.Device was not returned and no medical records were provided for review.Dhr review and related actions lot number was not provided, so dhr could not be reviewed.No actions required.This event is not related to any current actions or recalls or product holds.Device use and compatibility this device is used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.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 a revision was performed to remove a mobi-c device because of post-operative pain and disability.There are no reports of device malfunction associated with this event.

• Brand Name: IMPLANT MOBIC M ST 13X17 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 10300 ; FR 10300
• MDR Report Key: 11016260
• MDR Text Key: 221736299
• Report Number: 3004788213-2020-00211
• 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: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MB3375
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR