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

Device Problem Insufficient Information (3190)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Event Description

Information provided states that patient had 3 m6 discs implated in 2010.An m6-c was placed at c6/7 and 2 m6-ls were placed at l4/5, l5/6.Patient stated she had no pain relieve since devices were implanted.The area at c6/7 has osteophytes causing compression and has auto fused and compression on the spinal cord around the adr.Pt had surgery in (b)(6) 2022 to fuse.

Manufacturer Narrative

Additional information regarding the device has been requested.Without the part number or serial number of the device involved a review of the lot history records cannot be completed.

• 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
• MDR Report Key: 16261627
• MDR Text Key: 308345288
• Report Number: 3004987282-2022-00087
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2023

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
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/28/2023
• 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: 53 YR
• Patient Sex: Female