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

Catalog Number	CDL-637L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information provided states that patient had two (2) m6-c devices implanted at c4-c6 on an unknown date.Patient began experiencing swelling and difficulty swallowing.The two m6-c devices were explanted on (b)(6), 2024 and a posterior fixation was performed at c4-t1.
Additional Manufacturer Narrative
The device has not been returned for evaluation.The risk management files were reviewed and no new risks have been identified.Rmf 0003 rev 38 line 19.2.- dysphagia, hoarseness/dysphonia, vocal chord paralysis, airway obstruction, leading to major/surgical intervention, with explantation rmf 0003 rev 38 line 12.58.- infection, infected abscess or infected cyst (not involving resorption or osteolysis), leading to surgical/major intervention with explantation.
Additional Manufacturer Narrative
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 38 line 19.2.- dysphagia, hoarseness/dysphonia, vocal chord paralysis, airway obstruction, leading to major/surgical intervention, with explantation rmf 0003 rev 38 line 12.58.- infection, infected abscess or infected cyst (not involving resorption or osteolysis), leading to surgical/major intervention with explantation.Based on the inspection of the retrieved m6-c, in conjunction with the clinical data provided, the device did not fail mechanically.There was no evidence of collapse and there was no apparent loss of retention of the sheath.No radiographic images were provided to investigate the presence of bone resorption.The adjacent device at c4-c5 was also intact at time at removal and did not appear to fail mechanically.Destructive examination of the inner surfaces of the device is needed to examine the integrity of the fiber construct and the core.It is unclear whether infection played a role in the failure of this procedure, as no microbiological or histopathological lab results were provided; however, as difficulty swelling and fluid collection which had required drainage was noted, it is highly likely that infection was present at the time of removal, and not mechanical device failure.
Event or Problem Description
Devcie was returned for investigation.

• Brand Name: M6-C
• Common Device Name: ARTIFICIAL CERFICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury drive; sunnyvale 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury drive; sunnyvale 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale 94085
• MDR Report Key: 18870860
• Report Number: 3004987282-2024-00006
• Device Sequence Number: 3008526
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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: 02/01/2020
• Device Catalogue Number: CDL-637L
• Device Lot Number: 1439041
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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: 62 YR
• Patient Sex: Male