MAUDE Adverse Event Report: M6-C; ARTIFICIAL CERFICAL DISC

Catalog Number CDL-627

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2024

Event Type  Injury  

Manufacturer Narrative

The devices have been recieved for evaluation.Additional information has been requested regarding reason for removal.

Event Description

Information provided states that patient had m6-c's, artificial cervical disc, implanted at levels c5/6 - c6/7 at an unknown time.The two devices were explanted in (b)(6) 2024 due to unknown reasons.No additional information has been provided at this time.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERFICAL DISC
• MDR Report Key: 18718234
• MDR Text Key: 335528598
• Report Number: 3004987282-2024-00002
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/23/2020
• Device Catalogue Number: CDL-627
• Device Lot Number: 3214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2015
• 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): Other
• Patient Age: 67 YR
• Patient Sex: Female