MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 13X17 H5 US; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number	MB3375
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a mobi-c revision surgery was performed to address post-op migration due to a motor vehicle accident.The mobi-c was removed and converted to an acdf.
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 revision surgery was performed to address post-op migration due to a motor vehicle accident.The mobi-c was removed and converted to an acdf.
Additional Manufacturer Narrative
Additional information in h6: investigation type, findings, and conclusions.Device evaluation: the device was not returned, however the provided x-ray images appear to show injuries consistent with whiplash in the reported car accident.It looks like the facet joints are damaged, the superior plate has been crushed into the bone, and the inferior plate has become misaligned on the bone.Root cause: the provided x-ray images appear to show injuries consistent with whiplash in the reported car accident.It looks like the facet joints are damaged, the superior plate has been crushed into the bone, and the inferior plate has become misaligned on the bone.Dhr review: the dhr could not be located, a search for the dhr was conducted, however there is no such part/lot dhr that could be located.A search of sap for the part/lot combination was also conducted with no results.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 13X17 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: 21104145
• Report Number: 3004788213-2025-00000
• Device Sequence Number: 8665049
• Product Code: MJO
• UDI-Device Identifier: 03662663000093
• UDI-Public: (01)03662663000093(10)5386197
• 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: 2024
• Device Explanted Year: 2024
• 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): 06/29/2025

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: MB3375
• Device Lot Number: 5386197
• 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: 01/08/2025
• Supplement Report FDA Received Date: 06/30/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic