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

Model Number	CDL-637L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Osteomyelitis (4533)
Date of Event	05/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that an m6 was being explanted due to noted osteomyelitis.However, radiographic images were not provided for review.The device was not returned and therefore examination of the explant could not be completed.With the limited information provided, it is not possible to determine the cause of the reported failure for this product experience.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 that c5/6 oseomyolitis surgeon changed out for cage and plate to achieve fusion at site.Osteomyolitis was noted at superior and inferior endplates.Infection was present - observation of osteomyelitis on pre op mri and x-ray (identified by surgeon but not shared to attending rep, implant not available to return).
Event or Problem Description
It was reported that c5/6 oseomyolitis surgeon changed out for cage and plate to achieve fusion at site.Osteomyolitis was noted at superior and inferior endplates.Infection was present - observation of osteomyelitis on pre op mri and x-ray (identified by surgeon but not shared to attending rep, implant not available to return)).
Additional Manufacturer Narrative
Additional information has been requested, although it was confirmed the device will not be returned for further investigation.

• Brand Name: M6-C ARTIFICIAL CERVICAL DISC
• Common Device Name: M6-C
• 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: 22057093
• Report Number: 3004987282-2025-00012
• Device Sequence Number: 8347940
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• 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): 06/12/2025

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 Model Number: CDL-637L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Other
• Patient Sex: Male