MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT; CERVICAL DISK PROSTHESIS

Model Number N/A

Device Problems No Device Output (1435); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Not returned to manufacturer.

Event Description

Mobi-c p&f us : revision due to subsidence.No additional information provided at this time.A request was done to get information about this case.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.Date of report; if follow-up, what type were updated.With the lack of information about the device used, it's reference and lot number, review of the jde inventory records and of the device history records are impossible.Any comparison with previous similar events is also impossible.One information this investigation can rely on and that's the surgeon's conclusion which states that the event was probably not device-related and that there's no reasonable possibility that the adverse event may have been caused by the device.The cause for the device disassembly is unknown.The lack of information did not allow to understand at all if the surgical steps were followed or not.The investigation found that the event was not caused by the device.Root cause is unknown.

Event Description

Mobi-c p&f us : revision due to subsidence.No additional information provided at this time.A request was done to get information about this case.

• Brand Name: MOBI-C IMPLANT
• 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
• MDR Report Key: 6864194
• MDR Text Key: 86092622
• Report Number: 3004788213-2017-00081
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention