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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Information provided via abstract publication states that from m6 call with greg cunningham (case 5).M6 implanted at c5/6 in (b)(6) 2013 and patient deferred surgery with implant monitored annually.Revision due (b)(6) 2023.

Manufacturer Narrative

The device was not received for evaluation.No device identifiers; serial number, lot number, were not provided therefore a review of the lot history records could not be performed.A review of the risk management file resulted in no new risk associated with the device.Rmf 0003 rev 36 line 12.50.- device does not last expected lifetime not leading to surgical/major intervention.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury drive; sunnyvale CA 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury drive; sunnyvale CA 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale, CA 94085 ; 2149372015
• MDR Report Key: 17374676
• MDR Text Key: 319533600
• Report Number: 3004987282-2023-00038
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2023

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: 06/27/2023
• Initial Date FDA Received: 07/21/2023
• 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): Other
• Patient Age: 46 YR
• Patient Sex: Male