MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 15X19 H5 US; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number	MB3595
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
It was reported that a mobi-c revision surgery was performed due to anterior migration and involved explantation of c5/c6 and fusion with trelloss csa.
Event or Problem Description
It was reported that a mobi-c revision surgery was performed due to anterior migration, and involved explantation of c5/c6 and fusion with trelloss csa.
Additional Manufacturer Narrative
H6: additional method code: 4110.Corrections in d4: lot & udi numbers, d9, and h3.Additional information in d4: expiration date, e1: first name, h4, and h6: investigation type, findings, and conclusions.Device evaluation: the explanted device was returned for evaluation.The articulating surface of the polyethylene insert showed surface deformation, burnishing, multidirectional scratches, embedded debris, and machining marks.The superior and inferior endplates showed evidence iatrogenic damage.The provided x-ray shows that the inferior plate has migrated anteriorly so that it is sitting proud of the vertebral body.Root cause: this event could be attributed to inadequate disc prep, a post-op event that could have caused the implant to loosen, or unknown patient or surgical factors.The evaluation did not conclude that any damages or deficiencies of the devices were observed.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.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X19 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: 23650763
• Report Number: 3004788213-2025-00066
• Device Sequence Number: 4824462
• Product Code: MJO
• UDI-Device Identifier: 03662663000185
• UDI-Public: (01)03662663000185(17)251101(10)5374430
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2025
• 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): 01/19/2026

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: 10/31/2025
• Device Catalogue Number: MB3595
• Device Lot Number: 5374430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/25/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic