MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X19 H5 US; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problem Compatibility Problem (2960)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

Sales order was provided but lot number of the item is unreadable.Review of traceability, complaint data base and device history record can't be performed.As indicated into surgical technique the implant size selection is made by different trial steps (width & depth determination & trialing) and must be verified under x-rays images.From information provided, based on the recurrence of this type of event for this implant, it is assessed that the root cause is related to an user error : incorrect size selection.The investigation found no evidence to indicate a device issue.If additional informations were received about the prothesis that might impact the result of this investigation another report will be sent.We keep track and trend this type of issue.Device not returned to manufacturer.

Event Description

Mobi-c p&f us: in & out due to size changing from information reported, the implant listed as "in/out " on the sales order was a "sizing change by the surgeon " additional information was provided : "surgeon always uses trials", but reporter don't remember anymore details about the surgery.Surgery was completed successfully with another device.

• Brand Name: MOBI-C IMPLANT 15X19 H5 US
• Type of Device: CERVICAL DISK PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7797049
• MDR Text Key: 117587952
• Report Number: 3004788213-2018-00228
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• 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: MB3595
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 46 YR