MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X17 H5 US; CERVICAL DISC PROTHESIS

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032)

Event Date 05/03/2017

Event Type  Injury  

Manufacturer Narrative

The complaint have been received on (b)(6) 2018.Further informations was requested for investigation.Additional information have been received on (b)(6) 2018 and showed the information regarding the involved lot numbers.It was a two levels implantation.Despite the relaunch for "reveive" the information requested, we don't known if the two level was removed or which of the two lot numbers has been involved.The two lot numbers have been investigate.The first lot mb3575 5258404 was treated in another report medwatch 3004788213-2017-00107.According the additional information received on (b)(6) 2018, this report is performed for the second lot mb3575 5255511.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.Based on the product history records, the recurrence of this type of event and on the fact that the products couldn't be evaluated, the root cause of the event cannot be determined.Requests for additional information and product return did not receive a response.It could not even be possible to make hypothesis about the root cause of the event.The investigation found no evidence to indicate a device issue.No conclusion can be made with available inputs.Root cause: unknown.Device not returned.

Event Description

Mobi-c p&f us: revision due to lack of mobility, c4/5 lowed in extension.Patient is doing well.

• Brand Name: MOBI-C IMPLANT 15X17 H5 US
• Type of Device: CERVICAL DISC 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
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7898929
• MDR Text Key: 121073022
• Report Number: 3004788213-2018-00316
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Model Number: N/A
• Device Catalogue Number: MB3575
• Device Lot Number: 5255511
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2015
• 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: 43 YR