MAUDE Adverse Event Report: LDR MÉDICAL MOBI-C IMPLANT "M" STANDARD 13X15 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3355
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Neck Pain (2433)
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient reported that a mobi-c implant migrated post-operatively and is causing pain.The device was placed at level c5/6 and was a single level construct.The patient expects to have a revision surgery to remove the device.
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 a mobi-c implant migrated post-operatively and is causing pain.The device was placed at level c5/6 and was a single level construct.A revision surgery was performed to remove the device.
Additional Manufacturer Narrative
H6 additional investigation type code: 4111.Corrections in b5, d4: udi number, d9, g1, and h3.Additional information in d4: expiration date, h4, and h6: component, investigation type, findings, and conclusions.Inspection: the articulating surface of the polyethylene insert showed iatrogenic damage and multidirectional scratches consistent with minimal wear.Both endplates had evidence of iatrogenic damage that most likely occurred during the removal process.The x-rays do not show any evidence of plate or pe insert migration.There is remaining bone posteriorly on both the superior and inferior vertebral endplates.This suggests that the discectomy may not have been completed correctly.It is possible that the superior osteophytes were not completely removed and the depth size of the implant may be too short.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/highridge¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.There is remaining bone posteriorly on both the superior and inferior vertebral endplates.This suggests that the discectomy may not have been completed correctly, which could have contributed to this issue.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.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 13X15 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 7206965158
• MDR Report Key: 16973386
• Report Number: 3004788213-2023-00047
• Device Sequence Number: 16723879
• Product Code: MJO
• UDI-Device Identifier: 03662663000000
• UDI-Public: (01)03662663000000(17)240101(10)5332209
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2024

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: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: MB3355
• Device Lot Number: 5332209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 06/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic