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

Model Number	N/A
Medical Device Problem Codes	Disconnection (1171); Misassembled (1398); Positioning Problem (3009)
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: disassembled during surgery, in disc space.As reported, upon insertion of the mobic the distraction rack, the mobic rack, began to migrate away from the pins thus surgeon lost distraction.Implant became wedged in the space.In addition, the implant inserter was jammed up against the distraction rack legs.It was difficult to open the distraction rack thus surgeon needed to pivot the implant on the inserter to remove from the space and the 3 piece implant fell apart.No issues getting it out or any issues with the patient.Paused the case for about a minute.Additional information was requested.Investigation ongoing.
Additional Manufacturer Narrative
Corrections to all fields.This is a duplicate of report 3004788213-2019-00197.
Event or Problem Description
This report was created in error.It is a duplicate of 3004788213-2019-00197.

• Brand Name: MOBI-C IMPLANT 17X17 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: 8770987
• Report Number: 3004788213-2019-00208
• Device Sequence Number: 11273448
• Product Code: MJO
• UDI-Device Identifier: 03662663002028
• UDI-Public: 3662663002028
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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 the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/14/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 02/05/2020
• 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