MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 15X15 H6 US; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number	MB3556
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Code	Peripheral Nervous Injury (4414)
Date of Event	08/03/2025
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.The reporter provided a copy of voluntary medwatch 3500, but there is not a report number associated with it.
Event or Problem Description
It was reported that a revision surgery was performed to address radiculopathy caused by a post-op mobi-c core fracture at c5/c6.The superior endplate had also shifted forward to where it was 2-3mm proud of the vertebral body.The implant was removed and converted to acdf using competitive product.
Additional Manufacturer Narrative
H6: additional method code: 4110.Corrections in d4: udi number.Additional information in d4: expiration date, h4, and h6: investigation type, findings, and conclusions.Device evaluation: the device was not returned for evaluation.The provided x-rays show that the superior endplate has anteriorly migrated from the disc space.Additionally, the provided photo of the poly-core shows it has fractured into three pieces.Root cause: this event could be attributed to an event post-op as reported, or other unknown patient or surgical factors.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s 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.
Event or Problem Description
It was reported that a revision surgery was performed to address radiculopathy caused by a post-op mobi-c core fracture at c5/c6.The superior endplate had also shifted forward to where it was 2-3mm proud of the vertebral body.The implant was removed and converted to acdf using competitive product.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X15 H6 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: 22956704
• Report Number: 3004788213-2025-00050
• Device Sequence Number: 8404647
• Product Code: MJO
• UDI-Device Identifier: 03662663000079
• UDI-Public: (01)03662663000079(17)210401(10)5265454
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2017
• 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
• Report Date (Section B): 02/02/2026

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: 03/31/2021
• Device Catalogue Number: MB3556
• Device Lot Number: 5265454
• 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
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2016
• 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; Other; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic