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 Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Codes	Neck Pain (2433); Metal Related Pathology (4530); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed to address a mobi-c implant whose poly core migrated, causing the implant to collapse.
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.
Additional Manufacturer Narrative
Voluntary medwatch report mw5113620 was received from the user facility.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 that a revision surgery was performed to address a mobi-c implant whose poly core migrated and fractured, causing the implant to collapse.
Additional Manufacturer Narrative
Corrections in b5, d9,and h3.Additional information in b7, d6a, and h6: impact and clinical codes.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.
Event or Problem Description
It was reported that a revision surgery was performed to address a mobi-c implant whose poly core migrated and fractured, causing the implant to collapse.During the revision, an ent was called in to do an impromptu hemithyroidectomy due to metallosis.The mobi-c was converted to an acdf.
Event or Problem Description
It was reported that a revision surgery was performed to address a mobi-c implant whose poly core migrated and fractured, causing the implant to collapse.During the revision, an ent was called in to do an impromptu hemithyroidectomy due to metallosis.The mobi-c was converted to an acdf.
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 that a revision surgery was performed to address a mobi-c implant whose poly core migrated and fractured, causing the implant to collapse.During the revision, an ent was called in to do an impromptu hemithyroidectomy due to metallosis.The mobi-c was converted to an acdf.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the product was returned.The articulating surface of the polyethylene insert showed multidirectional scratches, burnishing, and pitting consistent with wear.The superior endplate, inferior endplate, and polyethylene insert had evidence of damage consistent with impingement.Overall the results of the analysis are consistent with a device having impingement.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: per dhr review, the part was likely conforming when it left zimvie control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 15940288
• Report Number: 3004788213-2022-00123
• Device Sequence Number: 6258120
• Product Code: MJO
• UDI-Device Identifier: 03662663000093
• UDI-Public: (01)03662663000093(17)210301(10)5268036
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/26/2023

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: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: MB3375
• Device Lot Number: 5268036
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2022
• Supplement Date Received by Manufacturer: 12/12/2022; 01/11/2023; 02/27/2023; 05/26/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 12/21/2022; 02/06/2023; 03/23/2023; 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2016
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 58 KG