MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT "M" STANDARD, UNKNOWN SIZE; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number MB3XXX

Device Problems Mechanical Problem (1384); Patient Device Interaction Problem (4001)

Patient Problem Ossification (1428)

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 a revision surgery was performed due to heterotopic ossification and device malfunction.No further information was provided.

Manufacturer Narrative

Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned and photos/ x-rays were not provided.Device evaluation could not be performed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review : dhr review unable to be performed as lot number not known.Device use: this device is used for treatment.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 a revision surgery was performed due to heterotopic ossification and device malfunction.No further information was provided.

• Brand Name: MOBI-C IMPLANT "M" STANDARD, UNKNOWN SIZE
• 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: 12506585
• MDR Text Key: 272478921
• Report Number: 3004788213-2021-00113
• 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: health professional,study
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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 Catalogue Number: MB3XXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/21/2021
• Supplement Dates Manufacturer Received: 10/08/2021
• Supplement Dates FDA Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention