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

Model Number	CDM-625
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested, although the device is not returning for investigation.
Event or Problem Description
It was reported that there was disc lucency and collapse of m6-c disc after patient had a fall and had neck pain, incidental finding.
Event or Problem Description
It was reported that there was disc lucency and collapse of m6-c disc after patient had a fall and had neck pain, incidental finding.
Additional Manufacturer Narrative
Additional information has been requested, although the device is not returning for investigation.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 12.60.- device damaged/broken leading to surgical intervention with explantation.Rmf 0003 rev 39 line 12.75 - device explanted.Rmf 0003 rev 39 line 15 - failure to relieve symptoms including unresolved pain.Rmf 0003 rev 39 line 12.45.- excessive height loss/disc collapse: < 1mm between endplates.Leading to surgical intervention, with explantation, involving patient with multiple cervical spinal implants.It was reported that there was lucency and collapse of m6c disc after patient had a fall and had neck pain.Radiographic images were provided for review.Lateral ct shows the cervical spine with disc replacement at c4/5, fusion at c5/6 and another disc replacement at c6/7.The fusion appears to have healed.The replacement at c6/7 appears appropriately sized and place with height retained.No radiolucency noted at this level.The c4/5 level shows radiolucency around both endplates and collapse of the disc.The c4/5 replacement also appears to have possibly fractured.Intra-op image shows the disc replacement at c4/5 has been removed.The fusion at c5/6 has healed and the implant at c6/7 appears normal with no obvious radiolucency.Microbiology/pathology reports and results were not provided.The device was not returned and therefore examination of the explant could not be completed.With the information provided, it is likely the patient fall/trauma contributed to the product experience.Should additional information be provided, the pe will be reopened, and the investigation amended.

• Brand Name: M6-C
• Common Device Name: ARTIFICAL 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: 21827540
• Report Number: 3004987282-2025-00010
• Device Sequence Number: 4210576
• Product Code: MJO
• UDI-Device Identifier: 00812388030018
• UDI-Public: 00812388030018
• 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: 2015
• 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): 04/25/2025

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: 11/01/2019
• Device Model Number: CDM-625
• Device Catalogue Number: FG0005-10
• Device Lot Number: 3616
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2014
• 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 Sex: Female