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

Catalog Number	CDL-627
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Neuropathy (1983); Implant Pain (4561)
Date of Event	06/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is currently pending evaluation.A review of the rmf did not result in any new risks associated with the device.Rmf 0003 rev 36 line 12.75 - device explanted.
Event or Problem Description
Information provided states that patient had m6-c implanted at c4/5 on (b)(6) 2021.The patient complained of increasing pain in the right shoulder and radiated down her arm.Images showed a slight anterolisthesis of c4/5 with some tilting of the prosthesis.The patient also had disc hernitations at c7-t2 which a fusion was performed dueing the removal of the m6-c device.Patient is currently on nsaids and antibiotics.

• Brand Name: M6-C
• Common Device Name: 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: 17425284
• Report Number: 3004987282-2023-00042
• Device Sequence Number: 20313862
• Product Code: MJO
• UDI-Device Identifier: 00812388030032
• UDI-Public: 00812388030032
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: CDL-627
• Device Lot Number: 1545610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2023
• Initial Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 63 KG