MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 13X15 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB3355

Device Problem Biocompatibility (2886)

Patient Problems Disability (2371); Reaction (2414); No Code Available (3191)

Event Date 05/19/2020

Event Type  Injury  

Manufacturer Narrative

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.Mw5095694.

Event Description

It was reported a patient experienced biological reaction to a mobi-c implant.The patient was revised.Patient states they are permanently disabled.

Manufacturer Narrative

Additional information in d4: expiration date and udi number, h4, and h6: method, results, and conclusions.Potential cause: the exact cause can not be determined since the device was not returned for evaluation.Complaint history: there were one (1) other complaints for similar events (non biocompatible) related to the same part number in the 12 months leading up to the notification date through to the present.Dhr review and related actions: per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use : this device is used for treatment.

Event Description

It was reported a patient experienced biological reaction to a mobi-c implant.The patient was revised.Patient states they are permanently disabled.

• Brand Name: IMPLANT MOBIC M ST 13X15 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: 10460707
• MDR Text Key: 204578740
• Report Number: 3004788213-2020-00127
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Catalogue Number: MB3355
• Device Lot Number: 5311731
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability