MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT "M" STANDARD 17X17 H6 US; MOBI-C CERVICAL DISC PROSTHESIS

Model Number	N/A
Medical Device Problem Codes	Misassembled (1398); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch is submitted to send the initial report of this complaint.The review of tracebaility and devices history records is ongoing.Product was not returned yet, no evaluation could be performed.Investigation still in progress.Not returned to manufacturer yet.
Event or Problem Description
Mobi-c p&f us : bottom enplate seems crooked.As reported by sales rep : upon opening the implant and the tech putting it on the inserter it was noticed that the bottom endplate of the device was crooked.Another implant of same size was used to complete the surgery without further complication.No patient impact or surgery delay were reported.Additional information was requested.Investigation ongoing.
Additional Manufacturer Narrative
The implant was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the dhr did not find any issues which would have contributed to this event.
Event or Problem Description
It was reported that during the procedure the bottom endplate of the implant looked crooked.An alternate was opened and used to complete the case.There were no reported patient impact.S.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 17X17 H6 US
• Common Device Name: MOBI-C 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: 8770973
• Report Number: 3004788213-2019-00207
• Device Sequence Number: 2038302
• Product Code: MJO
• UDI-Device Identifier: 03662663002028
• UDI-Public: 03662663002028
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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 Expiration Date: 12/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MB3776
• Device Lot Number: 5290568
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 04/30/2020
• 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
• Patient Age: 54 YR