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

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Numbness (2415); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initial report and the result of the investigation of this complaint.The review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.It was reported on january 14th 2019 that the hospital will not release implant without patient¿s consent.The reporter is still trying to secure patient¿s written consent.Therefore, no product evaluation could be performed until now.From the information provided based on the complaint report, the product history records and the recurrence of this type of event for this product, the investigation found no evidence to indicate a device related issue.Indeed, based on the x-ray provided, an incorrect preparation during the initial surgery (incorrect choice of size of implant or incorrect distraction, or incorrect discectomy), leading to an implant in kyphosis, combined to the patient's post-operative high activity level as reported, could have caused the reported implant migration.However, regarding of the absence of the device examination , and the lack of provided information the exact root cause remain undetermined.As mentioned in the ifu post operative field patients should be instructed in postoperative care procedures and should be advised of the importance of adhering to these procedures for successful treatment with the device including the avoidance of heavy lifting, repetitive bending, and prolonged or strenuous activity initially and for a period of weeks to months depending on the individual patient¿s progress and the stability and functioning of the implant.Root cause remain undetermined with probable hypothesis of poor preparation combined to patient post-op hyperactivity.If the product was returned and it examination add a value on this investigation.Another report will be sent.Device not returned.

Event Description

Mobi-c p&f us: revision due to migration of inferior plate.The exact event date was not reported.The distributor reported no clear mechanical event.Patient was camping and reported into shoulder and neck pain with left arm numbness.Had progressive pain with new x-ray.3 weeks later, showing c5/6, c6 implant endplate migration.Additional information received on january 2nd 2019: as far as the reporter knows the patient is doing well and is in good health.The reporter does not know if the patient smokes.The reporter does not believe it is considered as a trauma.Patient may have been doing yoga.Could have caused migration but there is no way the reporter can say for sure if that is what caused it.So that is unknown.The reporter cannot explain why medical professional did not allege a deficiency in the performance of the device.No images from initial surgery are available.Additional information received on january 14th 2019: the hospital will not release implant without patient¿s consent.The reporter is still trying to secure patient¿s written consent.Therefore, no product evaluation could be performed until now.

• Brand Name: MOBI-C IMPLANT 15X19 H5 US
• Type of Device: CERVIVAL 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: 8264343
• MDR Text Key: 133975791
• Report Number: 3004788213-2019-00016
• 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: 01/10/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MB3595
• Device Lot Number: 5305919
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2018
• 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: 49 YR