MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT 13X15 H5 US; MOBI-C CERVICAL DISC PROSTHESIS

Catalog Number	MB3355
Medical Device Problem Codes	Fracture (1260); Malposition of Device (2616)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Musculoskeletal problem (4535); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a mobi-c device was removed after the patient developed post-operative neck, shoulder, and arm symptoms, kyphosis, and the implant broke at level c6/7.During the revision, the superior end plate was found to be displaced and was not well-fixed.The mobi-c device was replaced with competitive fusion devices.
Additional Manufacturer Narrative
H6 clinical sign 4581 keyword: kyphosis.Without a product return, no product evaluation is able to be conducted.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.
Event or Problem Description
It was reported that a mobi-c device was removed after the patient developed post-operative neck, shoulder, and arm symptoms, kyphosis, and the implant broke at level c6/7.During the revision, the superior end plate was found to be displaced and was not well-fixed.The mobi-c device was replaced with competitive fusion devices.
Additional Manufacturer Narrative
H6 additional investigation type: 4110.Corrections in g1.Additional information in h6: component, investigation type, findings, and conclusions.Inspection the device was not returned, an x-ray image was provided but no conclusions could be drawn from it.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 highridge¿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.

• Brand Name: MOBI-C IMPLANT 13X15 H5 US
• Common Device Name: MOBI-C CERVICAL DISC PROSTHESIS
• Manufacturer (Section D): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 17388970
• Report Number: 3004788213-2023-00067
• Device Sequence Number: 14970612
• Product Code: MJO
• UDI-Device Identifier: 03662663000000
• UDI-Public: (01)03662663000000(17)221101(10)5303437
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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: Lay User/Patient
• Device Expiration Date: 12/19/2017
• Device Catalogue Number: MB3355
• Device Lot Number: 5303437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 07/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MB3355 LOT 5303437, INSTALLED C5/6
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American