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

Catalog Number	MB3375
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference report 3004788213-2022-00131.
Event or Problem Description
It was reported that a revision surgery was performed to remove two mobi-c devices at levels c5/6 and c6/7.The device at c6/7 subsided, went into kyphosis, and caused discomfort for the patient.The surgeon added a fusion construct once the mobi-c devices were removed.This is report one of two for this event.
Additional Manufacturer Narrative
Additional information in d4: expiration date, h4, and h6: component, investigation type, findings, and conclusions.Inspection the superior endplates and inferior endplates of both explanted devices had evidence of iatrogenic damage on the anterior edges of the components consistent with removal of the device.Polyethylene insert b also showed evidence of iatrogenic damage.Polyethylene inserts a and b showed machining marks on the articulating and backside surfaces.Overall, the results of the stage i analysis are consistent with devices having a short implantation time.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.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown surgical or patient factors.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 that a revision surgery was performed to remove two mobi-c devices at levels c5/6 and c6/7.The device at c6/7 subsided, went into kyphosis, and caused discomfort for the patient.The surgeon added a fusion construct once the mobi-c devices were removed.This is report one of two for this event.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 13X17 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: 16023818
• Report Number: 3004788213-2022-00130
• Device Sequence Number: 12512104
• Product Code: MJO
• UDI-Device Identifier: 03662663000093
• UDI-Public: (01)03662663000093(17)260401(10)5381401
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2022
• Device Explanted Year: 2022
• 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): 07/07/2024

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: 03/31/2026
• Device Catalogue Number: MB3375
• Device Lot Number: 5381401
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2021
• 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