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

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problems Pain (1994); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/30/2020

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 mobi-c implant failed.There is no additional information available at this time.

Manufacturer Narrative

This report is relating additional information.Device evaluation: product was not returned for evaluation and no photos were provided, so a device evaluation can not be performed.Potential cause root cause was unable to be determined.This event could possibly be attributed unknown patient factors or events during operation.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.A follow-up report will be submitted if additional information is received that changes the information provided in this report.

Event Description

It was reported that the patient felt pain about one year after a mobi-c device was implanted at level c4-5.Spondylolisthesis was found at the affected level approximately three years post-op.A revision was performed wherein the mobi-c device was removed and replaced with a fusion construct.The patient had a fusion at levels c5-7 approximately 8 years prior to the mobi-c installation.

• Brand Name: MOBI-C IMPLANT 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
• MDR Report Key: 11496253
• MDR Text Key: 242800272
• Report Number: 3004788213-2021-00029
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MB3555
• Device Lot Number: 5282857
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 05/14/2021
• 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
• Patient Weight: 57