MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT 15X17 H6 US; STERILE CERVICAL DISC PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch is submitted to send the initial report of this complaint.Lot number of concerned device is not known.Attempts to obtain additional information have been made and no answer has been provided yet.So far, is not possible to perform the review of traceability and devices history records.Product was not returned yet, no evaluation could be performed.Investigation still in progress.
Event or Problem Description
Mobi-c p&f us : instrument/implant malfunction.Instrument/implant malfunction.No more information provided.Additional information was requested.Investigation still in progress.
Additional Manufacturer Narrative
Correction to all fields.Additional information from the reporter determined the device was reported in error and there were no malfunctions.
Event or Problem Description
Additional information from the reporter determined the device was reported in error and there were no malfunctions.

• Brand Name: MOBI-C IMPLANT 15X17 H6 US
• Common Device Name: STERILE CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8788716
• Report Number: 3004788213-2019-00217
• Device Sequence Number: 2639230
• Product Code: MJO
• UDI-Device Identifier: 03662663000161
• UDI-Public: 3662663000161
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MB3576
• Device Lot Number: NO INFORMATION
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1