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

Catalog Number MB3355

Device Problems Fracture (1260); Malposition of Device (2616)

Patient Problems Failure of Implant (1924); Unspecified Musculoskeletal problem (4535); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/17/2020

Event Type  Injury  

Event 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.

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.

• Brand Name: MOBI-C IMPLANT 13X15 H5 US
• Type of Device: 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: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 17388970
• MDR Text Key: 319715816
• Report Number: 3004788213-2023-00067
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 03662663000000
• UDI-Public: (01)03662663000000(17)221101(10)5303437
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110009
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MB3355 LOT 5303437, INSTALLED C5/6
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American