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

Model Number	CDL-627L
Medical Device Problem Codes	Structural Problem (2506); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the surgeon performed second m6-c surgery on his patient.When he got access to the cervical spine he saw that there is something wrong with the first m6-c that he had put in 4 months ago.The core seemed unstable, the skin of the core had loosened and the endplates were shifted in an unusual way.There were no issues with the instruments reported.
Additional Manufacturer Narrative
Device has been requested for return to complete investigation.
Event or Problem Description
It was reported the surgeon performed second m6-c surgery on his patient.When he got access to the cervical spine he saw that there is something wrong with the first m6-c that he had put in 4 months ago.The core seemed unstable, the skin of the core had loosened and the endplates were shifted in an unusual way.There were no issues with the instruments reported.
Additional Manufacturer Narrative
Based on the inspection of the retrieved m6-c, in conjunction with the clinical data, the device did not fail mechanically.There was no evidence of device collapse and inspection of the endplates, fiber construct, and core indicated that only slight in vivo damage had occurred.While it was reported that "the skin of the core had loosened," the sheath was not provided for inspection and extraction damage was evident.No obvious loosening was apparent from the provided radiograph.No histopathology or microbiology were conducted, so it is unknown if infection was present at the time of removal.Therefore, the factors that led to the removal of this device were unclear, but the device had not failed mechanically at the time of removal.Rmf 0003 rev 39 line 12.11.- translation of one ep relative to the other leading to surgical intervention, with explantation, involving patient with only a single level m6-c rmf 0003 rev 39 line 12.75 - device explanted.

• 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: 20592928
• Report Number: 3004987282-2024-00044
• Device Sequence Number: 17779586
• Product Code: MJO
• UDI-Device Identifier: 00812388030032
• UDI-Public: 00812388030032
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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 Model Number: CDL-627L
• Device Catalogue Number: FG0005-14
• Device Lot Number: 1783357
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• 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: 28 YR
• Patient Sex: Female