MAUDE Adverse Event Report: LDR MEDICAL MOBI-C IMPLANT "M" STANDARD, UNKNOWN SIZE; MOBI-C CERVICAL DISC PROTHESIS

Catalog Number MB3XXX

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

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.

Event Description

It was reported a that revision surgery was performed to remove three of four implanted mobi-c devices because one "blew out." no further information was provided.This is report one of three for this event.

• Brand Name: MOBI-C IMPLANT "M" STANDARD, UNKNOWN SIZE
• 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: 18159721
• MDR Text Key: 328400591
• Report Number: 3004788213-2023-00124
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MB3XXX
• Was Device Available for Evaluation?: No
• 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): Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic