MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD 15X15 H5 US; MOBI-C CERVICAL DISC PROTHESIS

Catalog Number MB3555

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

Patient Problems Pain (1994); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

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 Description

It was reported that a revision surgery was performed for a mobi-c construct that was causing pain and numbness in the patient.During the revision surgery it was discovered that the left anterior corner of the mobile core had fractured, allowing the core to shift alignment and collapsing the posterior portion of the c3-c4 construct.The mobi-c was removed and replaced with an acdf.

• Brand Name: MOBI-C IMPLANT "M" STANDARD 15X15 H5 US
• Type of Device: MOBI-C CERVICAL DISC PROTHESIS
• 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: 18364910
• MDR Text Key: 331000918
• Report Number: 3004788213-2023-00143
• Device Sequence Number: 1
• Product Code: MJO
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MB3555
• Device Lot Number: 5324606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic