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

Catalog Number	CDL-627
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	08/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in this report was not made available for evaluation.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 device met the m6-c product specification including the axial stiffness and flexural resistance specifications.The risk management files were reviewed and no new risks were identified related to this device.Rmf 0003 rev 36 line 20 - spinal stenosis, spondylolisthesis, or retrolisthesis, leading to a surgical/major intervention with explantation.Rmf 0003 rev 36 line 12.29.- migration/loosening, chronic requiring additional surgery, without explantation, involving patient with an unknown number of cervical spinal implants, it was reported that a patient had an m6-c explanted due to persistent right arm radiculopathy and radiculitis as well as persistent right c5/6 severe foraminal stenosis.It was also reported that imaging in late 2021 showed a failed/loose dis.Radiographic images were not provided for review.Microbiology/pathology reports and results were also not provided.The device was not returned and therefore examination of the explant could not be completed, therefore it is not possible to determine the cause of the reported failure for this product experience.
Event or Problem Description
Information provided states that patient had an m6-c device implanted at level c5/6 in (b)(6)2020.Patient experienced right arm radiculopathy and radiculitis and c5/6 foraminal stenosis.The m6-c device was removed and replaced with a fusion in (b)(6) 2022.

• 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: 17650260
• Report Number: 3004987282-2023-00053
• Device Sequence Number: 7212843
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2023

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: 05/04/2024
• Device Catalogue Number: CDL-627
• Device Lot Number: 1292287
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2019
• 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: 44 YR
• Patient Sex: Female