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

Model Number	CDL-637L
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Osteolysis (2377); Medical device site infection (4845)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dr explanted an m6 and converted it to a fusion.Patient was admitted for infection of the device.It was reported that the device core was frayed.Osteolysis was noted on the form.
Additional Manufacturer Narrative
Additional information has been requested including the return of the device for investigation.
Additional Manufacturer Narrative
The build lhr was examined including the final inspection records and the in-process measurements.There was one ncmr associated with this lot.The devices met the m6-c product specification including the axial stiffness and flexural resistance specifications.The purpose of (b)(4) was to document the replacement of damaged boxes from product returned from the field per (b)(4) repackaging of devices.A total of (b)(4) devices were originally documented in the ncmr.(b)(4) devices were to be repackaged per (b)(4) and (b)(4) devices were to be scrapped as indicated in the preliminary disposition.Based on the inspection of the retrieved m6-c, in conjunction with the information provided, in vivo damage to the core and fiber construct had occurred; however, mechanical failure had not occurred.There was no evidence of collapse and the core appeared to have been retained at the time of removal.This device was likely removed due to the reported infection.However, due to the extent of the extraction damage and lack of radiographs, it is unclear if in vivo damage to the fiber construct also contributed to the reported osteolysis.Rmf 0003 rev 39 line 12.58.- infection, infected abscess or infected cyst (not involving resorption or osteolysis), leading to surgical/major intervention with explantation.Rmf 0003 rev 39 line 12.75 - device explanted.
Event or Problem Description
It was reported that dr explanted an m6 and converted it to a fusion.Patient was admitted for infection of the device.It was reported that the device core was frayed.Osteolysis was noted on the form.

• 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: 21200339
• Report Number: 3004987282-2025-00001
• Device Sequence Number: 8325808
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: 06/24/2025
• Device Model Number: CDL-637L
• Device Catalogue Number: FG0031-05
• Device Lot Number: 1506900
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2020
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 95 KG