MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 13X15 H5 US; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number	MB3355
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Headache (1880); Numbness (2415); Neck Pain (2433)
Date of Event	12/01/2025
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 patient presented with neck pain, headaches, and bilateral arm numbness approximately one year post-operatively.Images were taken which showed that the implant's inferior endplate and core dislodged and migrated well beyond the posterior border of the patient's vertebral body and into the foramen/spinal canal.A revision surgery was performed to safely remove the implant and replace with an acdf.
Event or Problem Description
It was reported that a mobi-c patient presented with neck pain, headaches, and bilateral arm numbness approximately one year post-operatively.Images were taken which showed that the implant's inferior endplate and core dislodged and migrated well beyond the posterior border of the patient's vertebral body and into the foramen/spinal canal.A revision surgery was performed to safely remove the implant and replace with an acdf.
Additional Manufacturer Narrative
H6: additional patient codes: 4526, 2434, 2432, 1979.Additional information in g2 and h6: patient and impact codes.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.A review of the dhr was conducted and found no indications of manufacturing issues.The device was not returned but x-rays were provided and reviewed as part of this investigation.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for mobi- c implant for the failure of migration resulting in migration.A definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown patient or surgical factors.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.
Event or Problem Description
It was reported that a mobi-c patient presented with neck pain, headaches, and bilateral arm numbness approximately one year post-operatively.Images were taken which showed that the implant's inferior endplate and core dislodged and migrated well beyond the posterior border of the patient's vertebral body and into the foramen/spinal canal.A revision surgery was performed to safely remove the implant and replace with an acdf.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 13X15 H5 US
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 23975765
• Report Number: 3004788213-2026-00000
• Device Sequence Number: 10717876
• Product Code: MJO
• UDI-Device Identifier: 03662663000000
• UDI-Public: (01)03662663000000(17)261201(10)5396701
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/26/2026

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 Catalogue Number: MB3355
• Device Lot Number: 5396701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/11/2026; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic