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	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to remove two mobi-c devices because they were locked in a hyperlordotic position in flexion and extension.This is report one of two for this event.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.Reference report 3004788213-2022-00133.
Event or Problem Description
It was reported that a revision surgery was performed to remove two mobi-c devices because they were locked in a hyperlordotic position in flexion and extension at c3/4 and c4/5.The patient also had dysphagia.The poly core was protruding anteriorly and subsided at c4/5.A corpectomy with fusion was performed at c4 during the revision.This is report one of two for this event.
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
It was reported a revision surgery was performed to remove two mobi-c devices because they were locked in a hyperlordotic position in flexion and extension at c3/4 and c4/5.The patient also had kyphosis that led to dysphagia, but no pain.The poly core was protruding anteriorly and subsided at c4/5.A corpectomy with fusion was performed at c4 during the revision.This is report one of two for this event.
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.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.Inspection: x-rays were provided which show that both implants are in a hyperlordotic or "fish mouth" position.Migration of the poly core could not be confirmed from the provided x-rays.The devices were sent to a lab for review.The lab provided photos of the devices which show that one of the poly cores is fractured.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the devices were likely conforming when they 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 patient or surgical 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 a revision surgery was performed to remove two mobi-c devices because they were locked in a hyperlordotic position in flexion and extension at c3/4 and c4/5.The patient also had kyphosis that led to dysphagia, but no pain.The poly core was protruding anteriorly and subsided at c4/5.A corpectomy with fusion was performed at c4 during the revision.This is report one of two for this event.

• 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16024005
• Report Number: 3004788213-2022-00132
• Device Sequence Number: 20556531
• Product Code: MJO
• UDI-Device Identifier: 03662663000000
• UDI-Public: (01)03662663000000(17)221001(10)5300162
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: 2018
• 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,Followup,Followup
• Report Date (Section B): 07/13/2023

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: Other
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: MB3355
• Device Lot Number: 5300162
• Was Device Available for Evaluation?: No
• 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: 01/02/2023; 02/14/2023; 02/14/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 01/27/2023; 03/15/2023; 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2017
• 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