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

Catalog Number	MB3375
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Subluxation (4525)
Date of Event	06/27/2021
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
A patient reported that the mobile core and inferior plate of a mobi-c implant were found to have migrated post-operatively at level c6/7.A revision surgery was performed to convert the patient to a fusion.
Additional Manufacturer Narrative
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
A patient reported that the mobile core and inferior plate of a mobi-c implant were found to have migrated post-operatively at level c6/7.A revision surgery was performed to convert the patient to a fusion.
Additional Manufacturer Narrative
H6: additional investigation type code: 4110.Device evaluation: the device was not returned for evaluation and no photos or x-rays were provided, so the complaint remains unrefuted.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to 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 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
A patient reported that the mobile core and inferior plate of a mobi-c implant were found to have migrated post-operatively at level c6/7.A revision surgery was performed to convert the patient to a fusion.

• Brand Name: MOBI-C IMPLANT "M" STANDARD, 13X17 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROTHESIS
• Manufacturer (Section D): LDR MEDICAL; 5 rue de berlin; parc d'entreprises du grand tr; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de brelin; parc d'entreprises du grand tr; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17389356
• Report Number: 3004788213-2023-00066
• Device Sequence Number: 14398941
• Product Code: MJO
• UDI-Device Identifier: 03662663000093
• UDI-Public: (01)03662663000093(17)250101(10)5357791
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2023

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: 12/31/2024
• Device Catalogue Number: MB3375
• Device Lot Number: 5357791
• 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; Not provided
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/23/2023; 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• 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: 53 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic