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

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Unspecified Infection (1930)

Event Date 08/03/2023

Event Type  Injury  

Event Description

Information provided states that an m6-c was implanted at c5/6 on an unknown date appx 4 yrs ago.On august 3rd, the patient underwent an add-on trauma where the m6-c was explanted and an acdf was performed at level c5/6.During the removal, the implant had loosening and an abcess was found at the c5/6 level.

Manufacturer Narrative

Additional information related to the incident and the device information have not been made available.A review of the lhr cannot be performed without the lot number or device.The risk management files have been reviewed and no new risks have been identified based on the information provided.Rmf 0003 rev 36 line 12.26.- migration/loosening, chronic, requiring additional surgery, with explantation, involving patient with only a single level m6-c rmf 0003 rev 36 line 12.58.- infection, infected abscess or infected cyst (not involving resorption or osteolysis), leading to surgical/major intervention with explantation.Rmf 0003 rev 36 line 12.75 - device explanted.

• 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: 17674119
• MDR Text Key: 322597069
• Report Number: 3004987282-2023-00054
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• 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: 08/03/2023
• 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: 62 YR
• Patient Sex: Male