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

Device Problems Loss of Osseointegration (2408); Patient-Device Incompatibility (2682)

Patient Problem Unspecified Infection (1930)

Event Date 09/23/2021

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.This was a three-level implantation.Implantation occurred in (b)(6).The risk management files were reviewed and no new risks were identified.

Event Description

Patient had three levels implanted in (b)(6).Us surgeon removed one level at c5/6 due to alleged infection and implant loosening.The surgeon removed one device.Patient is doing well.Two devices remain implanted.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 CA 94085
• Manufacturer (Section G): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale CA 94085
• Manufacturer Contact: peter kollings ; 501 mercury drive; sunnyvale, CA 94085
• MDR Report Key: 12669013
• MDR Text Key: 277723625
• Report Number: 3004987282-2021-00048
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/20/2021
• 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