MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 15X15 H5 US; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number	MB3555
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Neuropathy (1983); Pain (1994); Skin Burning Sensation (4540)
Date of Event	01/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was initially reported on mw5176775.D4: the remainder of the udi number is unknown because the lot number is not available.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore, the device history records are unable to be reviewed.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 via voluntary medwatch that they received a mobi-c implant and began experiencing a sharp, tingling sensation in their left arm and additionally pain post-operatively.X-rays revealed that the disc needs to be replaced due to migration.The patient is currently obtaining a second opinion and no surgery is scheduled yet.
Event or Problem Description
A patient reported via voluntary medwatch that they received a mobi-c implant and began experiencing a sharp, tingling sensation in their left arm and additionally pain post-operatively.X-rays revealed that the disc needs to be replaced due to migration.The patient is currently obtaining a second opinion and no surgery is scheduled yet.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.The device was not returned and no photos were provided, so an evaluation is unable to be performed.The lot number was not reported and the device was not returned, therefore a dhr review is unable to be performed.The complaint is unrefuted for mobi-c implant for the failure of migration and patient pain.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.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X15 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: 23650425
• Report Number: 3004788213-2025-00065
• Device Sequence Number: 14658702
• Product Code: MJO
• UDI-Device Identifier: 03662663000062
• UDI-Public: (01)03662663000062
• 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: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2026

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 Catalogue Number: MB3555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 11/25/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 62 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American