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

Model Number	6ML
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has been returned to manufacturer and is pending evaluation.The build lhr for cdm-635l 1290938 adw627 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.A review of the risk management files revealed no new risks associated with the device.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.
Event or Problem Description
Information provided states that pt had two (2) m6-c artificial cervical discs implanted in 2019.The patient presented with a mass in the throat.Inflammation was suspected and both of the devices were removed and replaced with acdf (anterior cervical discectomy and fusion).
Event or Problem Description
Information provided states that pt had two (2) m6-c artificial cervical discs implanted in 2019.The patient presented with a mass in the throat.Inflammation was suspected and both of the devices were removed and replaced with acdf (anterior cervical discectomy and fusion).
Additional Manufacturer Narrative
Device has been returned to manufacturer and is pending evaluation.The build lhr for cdm-635l 1290938 adw627 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.A review of the risk management files revealed no new risks associated with the device.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 based on the inspection of the retrieved m6-c, in conjunction with the clinical data and images provided, the devices did not fail mechanically.There was no evidence of collapse and the sheaths remained present between the endplates, with the fiber and core, presumably present in both devices.Bone resorption around the device was not observed in the pre-revision images.Destructive examination of the inner surfaces of the devices is needed to examine the integrity of the fiber construct and the core.It was reported that a mass was present in the throat; however, no additional information was provided about the mass and no lab results were provided.Therefore, while both devices located at c5-c6 and c6-c7 were clearly removed due to the presence of the mass, it unknown if the devices contributed formation of the mass.It should also be noted that 2-level m6-c is not indicated for use in the us and, therefore, this pe is considered off-label use.

• 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
• MDR Report Key: 16902190
• Report Number: 3004987282-2023-00019
• Device Sequence Number: 15165370
• Product Code: MJO
• UDI-Device Identifier: 00812388030025
• UDI-Public: 00812388030025
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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 Expiration Date: 04/23/2024
• Device Model Number: 6ML
• Device Catalogue Number: CDM-635L
• Device Lot Number: 1290938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/10/2023
• Supplement Report FDA Received Date: 06/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2019
• 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: 53 YR
• Patient Sex: Female