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

Model Number	CDM-625
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dr.(b)(6) experienced an m6-c device failure which was subsequently explanted from one of his patients.Dr.(b)(6) requested that the explanted device be returned for internal inspection.According to information obtained from the patient's husband, the patient previously had a prodisc implanted (implant date unknown) and later underwent a revision procedure in 2020 performed by dr.(b)(6).The patient was initially informed that a cage would be implanted, however intraoperatively dr.(b)(6) elected to implant a two-level m6-c.The patient later presented to dr.(b)(6), who explanted both of the m6-c devices on (b)(6) 2025.The patient's husband reported that the patient has experienced chronic pain for several years and that bone resorption had begun.No images were provided.No additional information is available at this time.
Additional Manufacturer Narrative
The device has returned for investigation but analysis is not complete.
Event or Problem Description
It was reported that dr.(b)(6) experienced an m6-c device failure which was subsequently explanted from one of his patients.Dr.Sikora requested that the explanted device be returned for internal inspection.According to information obtained from the patient's husband, the patient previously had a prodisc implanted (implant date unknown) and later underwent a revision procedure in 2020 performed by dr.(b)(6).The patient was initially informed that a cage would be implanted; however intraoperatively dr.Khachatryan elected to implant a two-level m6-c.The patient later presented to dr.(b)(6), who explanted both of the m6-c devices on (b)(6) 2025.The pateint's husband reported that the patient has experienced chronic pain for several years and that bone resorption had begun.No images were provided.No additional information is available at this time.
Additional Manufacturer Narrative
Based on the inspection of the retrieved m6-c, in the absence of additional clinical data, the device had not failed mechanically at the time of removal.Some in vivo damage was noted to the core and to the fiber construct; however, extraction damage was also present, indicating that the device was likely grossly intact at the time of removal and had not collapsed at the time of removal.While it was reported by the patient's spouse that "resorption" had occurred, no radiographs, radiographic findings, histopathology, or microbiology findings were provided.Due to the extent of the extraction damage and lack of additional clinical information, the sequelae of events that contributed to the failure of this procedure is unclear.Rmf 0003 rev 40 line 15 - failure to relieve symptoms including unresolved pain.Rmf 0003 rev 40 line 12.73.10 - resorption withoutinfection/infectedabscess/infected cyst, leading to surgical intervention with explantation.Rmf 0003 rev 40 line 12.75 - device explanted.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.

• Brand Name: M6-C
• Common Device Name: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury dr; sunnyvale 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury dr; sunnyvale 94085
• Manufacturer Contact: yobana sanchez ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 23227760
• Report Number: 3004987282-2025-00023
• Device Sequence Number: 21206261
• Product Code: MJO
• UDI-Device Identifier: 00812388030018
• UDI-Public: 00812388030018
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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: CDM-625
• Device Catalogue Number: FG-0005-01
• Device Lot Number: 1539801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• 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: 39 YR
• Patient Sex: Female