MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT "M" STANDARD 15X17 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3575
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Event or Problem Description
It was reported that a mobi-c implant disassociated where the upper endplate retrolisthesed and the implant kicked into hyperlordosis.There are plans to perform a revision surgery to remove the mobi-c and convert it to a fusion.The patient continues to have neck pain.
Event or Problem Description
It was reported, that a mobi-c implant disassociated, where the upper endplate retrolisthesed and the implant kicked into hyperlordosis.There are plans to perform a revision surgery to remove the mobi-c and convert it to a fusion.The patient continues to have neck pain.
Additional Manufacturer Narrative
Component, investigation type, findings, and conclusions.Device evaluation: product not returned.And no x-rays were provided.Device evaluation unable to be completed.Root cause: root cause was unable to be determined.This event could possibly be attributed to unknown operational, patient or post-operative trauma factors.Dhr review: per, dhr review, the part was likely conforming, when it left zimvie control.Device usage: this device is used for treatment.If additional information is obtained, that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X17 H5 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, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 15831021
• Report Number: 3004788213-2022-00106
• Device Sequence Number: 17411222
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: (01)03662663000154(17)251101(10)5374401
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2025
• Device Catalogue Number: MB3575
• Device Lot Number: 5374401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 11/19/2022
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White