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

Catalog Number	MB3575
Medical Device Problem Codes	Osseointegration Problem (3003); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994)
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
A patient reported experiencing pain with two-level mobi-c implants at c5/6 and c6/7 approximately 6.5 years post-operatively.The patient has used medication and physical therapy and still experiences pain.Follow-up x-rays and mris were inconclusive, and the surgeon suggested possible implant removal, however the patient does not want to do so unless absolutely necessary.The patient tested negative for allergy to mobi-c components.Another x-ray was taken and shows what appears to be calcification over one of the implants and no movement of it.The patient continues to consult their doctor to determine next steps.This is report one of two for this event.
Event or Problem Description
A patient reported experiencing pain with two-level mobi-c implants at c5/6 and c6/7 approximately 6.5 years post-operatively.The patient has used medication and physical therapy and still experiences pain.Follow-up x-rays and mris were inconclusive, and the surgeon suggested possible implant removal, however the patient does not want to do so unless absolutely necessary.The patient tested negative for allergy to mobi-c components.Another x-ray was taken and shows what appears to be calcification over one of the implants and no movement of it.The patient continues to consult their doctor to determine next steps.This is report one of two for this event.
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 and no photos were provided, so an evaluation is unable to be performed.This event likely cannot be attributed to manufacturing or design related issues.The complaint is confirmed for mobi-c implant for pain but unrefuted for binding.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.Reference report 3004788213-2025-00062.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X17 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: 23417422
• Report Number: 3004788213-2025-00061
• Device Sequence Number: 21089633
• Product Code: MJO
• UDI-Device Identifier: 03662663000154
• UDI-Public: (01)03662663000154(17)230601(10)5317005
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: MB3575
• Device Lot Number: 5317005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• 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: Other
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic