MAUDE Adverse Event Report: SPINAL KINETICS LLC M6-C; ARTIFICIAL CERVICAL DISC

Device Problem Insufficient Information (3190)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/16/2021

Event Type  Injury  

Manufacturer Narrative

Additional information and the return of the device has been requested.Without a device, serial number or lot number, the device history records review could not be completed.The risk management files were reviewed and no new risks were identified.

Event Description

Patient with m6-c device was revised.The device was explanted.The condition of the device at the time of removal is unknown.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale 94085
• Manufacturer (Section G): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale CA 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale, CA 94085
• MDR Report Key: 12973371
• MDR Text Key: 282032578
• Report Number: 3004987282-2021-00059
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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