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

Model Number	CDL-627
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a removal/revision case because the implant failed.The original case was on (b)(6) 2022.A plate and cage were used on the revision.
Additional Manufacturer Narrative
Additional information has been requested including the device return for investigation.
Additional Manufacturer Narrative
Device was returned for investigation.Based on the inspection of the retrieved m6-c, in conjunction with the limited clinical data, the condition of the device at the time of removal was unclear.Specifically, the sheath, fiber construct, and core were not submitted with the device and could not be inspected; however, there was no evidence of in vivo contact between the endplates.No lab results or radiographs were submitted with the device.Therefore, without further clinical or radiographic information, the mechanical condition of the device at the time of removal was unclear.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 12.75 - device explanted rmf 0003 rev 39 line 12.60.- device damaged/broken leading to surgical intervention with explantation.
Event or Problem Description
It was reported that there was a removal/revision case because the implant failed.The original case was on (b)(6) 2022.A plate and cage were used on the revision.

• Brand Name: M6 CERVICAL
• Common Device Name: ARTIFICIAL 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: avinash thite ; 501 mercury dr; sunnyvale, CA 94085
• MDR Report Key: 20969256
• Report Number: 3004987282-2024-00048
• Device Sequence Number: 3955156
• Product Code: MJO
• UDI-Device Identifier: 00812388030032
• UDI-Public: 00812388030032
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: 06/14/2026
• Device Model Number: CDL-627
• Device Catalogue Number: FG0005-05
• Device Lot Number: 1682897
• 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: 12/13/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• 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: Unknown