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

Model Number	CDL-627
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Sinusitis (4844)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further investigation pending the receipt of the device return.Additional information has been requested.
Event or Problem Description
It was reported there was a revision of c5/6 m6-c.Planned to replace it with an acdf or corpectomy using autograft and plate for fixation.
Additional Manufacturer Narrative
The retrieval analysis based on the images provided suggests that the device had not experienced mechanical failure at the time of removal.Extraction damage on the sheath, fiber construct, and core suggest that the device was grossly intact at the time of removal.Further, extraction damage and bony ongrowth indicate that the device was likely to have been fixed.The provided information indicated that infection was suspected as the cause of a chronic sinus infection; however, it is unclear if that theory was disproven by the surgical findings, or if the removal of the device resulted in relief from the sinus infection.Therefore, it is unknown if the device contributed to the sinus infection symptoms; however, mechanical failure had not occurred at the time of removal.The build lhr was examined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with this lot.The devices met the m6-c product specification including the axial stiffness and flexural resistance specifications.Rmf 0003 rev 39 line 12.58.- infection, infected abscess or infected cyst (not involving resorption or osteolysis), leading to surgical/major intervention with explantation.Rmf 0003 rev 39 line 12.75 - device explanted.
Event or Problem Description
It was reported there was a revision of c5/6 m6-c.Planned to replace it with an acdf or corpectomy using autograft and plate for fixation.

• Brand Name: M6-C
• Common Device Name: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury dr; sunnyvale CA 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury dr; sunnyvale CA 94085
• Manufacturer Contact: ayesa kearns ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 21713483
• Report Number: 3004987282-2025-00009
• Device Sequence Number: 21317562
• Product Code: MJO
• UDI-Device Identifier: 00812388030032
• UDI-Public: 00812388030032
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: 07/01/2022
• Device Model Number: CDL-627
• Device Catalogue Number: FG0005-14
• Device Lot Number: 8408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2017
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 107 KG