MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 13X15 H5 US; CERVICAL DISK PROTHESIS

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395)

Patient Problem Neck Pain (2433)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initial report and the results of the investigation.Product was not returned to ldr medical.No visual and functional evaluation can be performed.The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Based on the product history records, the review of the case, the recurrence of this type of event for this implant and on the fact that the product couldn't be evaluated, the root cause of the event cannot be determined.The likely hypothesis is a poor preparation of the intersomatic space and a parallel distraction which is probably incomplete.The investigation found no evidence to indicate a device issue.No conclusion can be made with available inputs.Root cause: unknown with hypothesis of a poor distraction and a poor preparation of intersomatic space.

Event Description

Mobi-c p&f us: migration of the inferior plate.The reporter received a phone call from physician.He had a patient experiencing neck pain.Upon further evaluation of the x-rays, surgeon believed the prosthesis to be loose at c5-c6, specifically migration of the inferior endplate.The initial surgery was performed on (b)(6) 2018 during a 2 levels surgery.No complication reported during first surgery.Revision surgery performed on (b)(6) 2018.Patient was involved in a car accident, however this was a week after the x-rays had been taken that showed evidence of loosening and implant migration of the inferior endplate.First and second surgery not performed in the same health care center.First: (b)(6).Second: (b)(6).After several attempts to obtain the post-op x-ray of the first surgery.No answer provided by the reporter.

• Brand Name: MOBI-C IMPLANT 13X15 H5 US
• Type of Device: CERVICAL DISK PROTHESIS
• 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: 8244238
• MDR Text Key: 133080714
• Report Number: 3004788213-2019-00007
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3355
• Device Lot Number: 5302369
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 48 YR