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 3004788213-2022-00130.
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 two of two for this event.
Additional Manufacturer Narrative
H6 additional investigation type code: 4110.Corrections in d4: udi number, g1, and h3.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 two 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: 16023819
• Report Number: 3004788213-2022-00131
• Device Sequence Number: 20582521
• Product Code: MJO
• UDI-Device Identifier: 03662663000093
• UDI-Public: (01)03662663000093(17)260701(10)5384951
• 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: 06/30/2026
• Device Catalogue Number: MB3375
• Device Lot Number: 5384951
• 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: 09/13/2021
• 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