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

Model Number	CDL-627
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Codes	Osteolysis (2377); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further investigation is pending the device return.
Event or Problem Description
It was reported that a surgeon had to revise an m6 prosthesis.It is alleged the device has to be destroyed to get it out of the patient but it already appeared being not intact in-situ (shifted end plates/ damaged core skin).
Additional Manufacturer Narrative
Based on the inspection of the retrieved m6-c, in the absence of additional clinical data, the device was removed due to osteolysis.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.However, the observed in vivo fiber damage likely contributed to the reported osteolysis.Due to the extent of the extraction damage and lack of additional clinical information, the sequelae of events that contributed to the removal of this device is 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 12.60.- device damaged/broken leading to surgical intervention with explantation.Rmf 0003 rev 39 line 12.75 - device explanted.Rmf 0003 rev 39 line 12.73.4.- resorption or osteolysis, without infection/infected.Abscess/infected cyst, leading to surgical intervention with explantation.
Event or Problem Description
It was reported that a surgeon had to revise an m6 prosthesis.It is alleged the device has to be destroyed to get it out of the patient but it already appeared being not intact in-situ (shifted end plates/ damaged core skin).

• Brand Name: M6-C
• 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: ayesa kearns ; 3451 plano pkwy; lewisville, TX 75056
• MDR Report Key: 21713007
• Report Number: 3004987282-2025-00008
• Device Sequence Number: 4539540
• 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 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): 05/14/2025

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: 04/01/2020
• Device Model Number: CDL-627
• Device Lot Number: 4518
• 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: 03/21/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2015
• 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