MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT 17X19 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3795
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
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
It was reported the inferior plate of a mobi-c implant migrated posteriorly post-operatively.A revision surgery was performed to remove the device.
Additional Manufacturer Narrative
H6 method: 4109.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed only the superior plate (mb084k lot 5343226), the inferior plate (mb125k lot 5343239) and the polyethylene insert were returned.No damage was noticed on either plate, however the insert has nick and gouges in it.These are likely the result of removing the implant.The complaint is confirmed via the provided x-rays where mobile core and inferior endplate posterior migration can be seen.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to patient or surgery specific 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 zimvie¿s control.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported the inferior plate of a mobi-c implant migrated posteriorly post-operatively.A revision surgery was performed to remove the device.
Event or Problem Description
It was reported a revision surgery was performed to address a mobi-c implant that migrated post-operatively.One month after surgery, the lower plate was prolapsed into the spinal canal.The revision was performed to replace the mobi-c implant with an acdf device even though the patient was asymptomatic.
Additional Manufacturer Narrative
Corrections in h6: patient code.Corrections were made based on additional information received from the reporter.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 17X19 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROSTHESIS
• 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: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17970076
• Report Number: 3004788213-2023-00088
• Device Sequence Number: 7754466
• Product Code: MJO
• UDI-Device Identifier: 03662663002042
• UDI-Public: (01)03662663002042(17)250201(10)5346710
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110009
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/29/2024

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: 01/31/2025
• Device Catalogue Number: MB3795
• Device Lot Number: 5346710
• Was Device Available for Evaluation?: Yes
• 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; Not provided
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 01/05/2024; 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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: 42 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic