MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT MOBIC M ST 13X15 H5 US; MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)

Model Number	N/A
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch is submitted to send the initial report of this complaint.Product was not returned yet, no evaluation could be performed.The review of the device history records is ongoing.Investigation still in progress.Not returned to manufacturer yet.
Event or Problem Description
Mobi-c p&f us : in/out.As reported, there was a in/out in surgery performed at (b)(6) medical center on (b)(6) 2018.No more information provided.Additional information was requested.Investigation ongoing.
Event or Problem Description
A mobi-c implant was implanted in a patient and later removed in the same surgery.No further surgical or patient information was provided.
Additional Manufacturer Narrative
Correction: a1, a2 (age), b5, b6, b7, d1, d2 (common device name), d4 (udi number), d10, e1 (contact), e2, e3, g3, h1, h3, h4, h6 (method).Additional info: e1 (state, zip code, telephone number), g5, h6 (results and conclusions codes.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.

• Brand Name: IMPLANT MOBIC M ST 13X15 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION)
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8788704
• Report Number: 3004788213-2019-00213
• Device Sequence Number: 1999914
• Product Code: MJO
• UDI-Device Identifier: 03662663000000
• UDI-Public: 03662663000000
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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: 12/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MB3355
• Device Lot Number: 5283612
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 03/25/2020
• 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: 60 YR