MAUDE Adverse Event Report: LDR MEDICAL IMPLANT MOBIC M ST 13X17 H6 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3376
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2022
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.
Event or Problem Description
It was reported that a mobi-c implant migrated anteriorly post-operatively.A revision surgery was performed where the device was removed and replaced with another mobi-c of the same size.
Event or Problem Description
It was reported that a mobi-c implant migrated anteriorly post-operatively.A revision surgery was performed where the device was removed and replaced with another mobi-c of the same size.
Additional Manufacturer Narrative
Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Inspection: the x-ray images that were provided show that the inferior endplate and poly core have migrated completely out of the disc space.The implant was also examined and the following was found: "the articulating surface of the polyethylene insert showed machining marks and multidirectional scratches consistent with minimal wear.Overall the results of the analysis are consistent with a device having short implantation time.Further analysis was conducted to assess the condition of the polyethylene insert.This analysis found a low oxidation level of the insert (oi < 1) and mechanical properties consistent with this level of oxidation." 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 patient or surgical factors, such as the patient aggressively cracking their neck, as mentioned by the surgeon.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: IMPLANT MOBIC M ST 13X17 H6 US
• Common Device Name: MOBI-C CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 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: 15178764
• Report Number: 3004788213-2022-00058
• Device Sequence Number: 5034597
• Product Code: MJO
• UDI-Device Identifier: 03662663000109
• UDI-Public: (01)03662663000109(17)250701(10)5368288
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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: 07/01/2025
• Device Catalogue Number: MB3376
• Device Lot Number: 5368288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2022
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 31 YR
• Patient Sex: Male