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

Model Number	CDL-627
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Numbness (2415); Neck Pain (2433); Vertebral Fracture (4520)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the study subject (b)(6) was treated in the m6-c 2 level ide on (b)(6)2024.The patient was seen on (b)(6) 2024 for the 6-month post-op study visit and reported achy pain in the neck along with numbness and tingling in fingers 2,3, & 4.Imaging showed increased angulation of the superior c6 hardware.A ct scan obtained on (b)(6) 2024 confirmed a spinal compression fracture at c6 (collapse c6 vertebrae).
Additional Manufacturer Narrative
This event was related to a study ide patient (b)(6).Additional information has been requested as the surgeon wants to proceed with a posterior fusion and supplemental fixation with possible decompression.Posterior fusion at c5-6 currently pending - date to be confirmed.There are currently no plans to remove the implant.

• 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: avinash thite ; 501 mercury dr; sunnyvale, CA 94085
• MDR Report Key: 20605234
• Report Number: 3004987282-2024-00045
• Device Sequence Number: 7346388
• Product Code: MJO
• UDI-Device Identifier: 00812388030032
• UDI-Public: 00812388030032
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2024

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-627
• Device Catalogue Number: FG0005-05
• Device Lot Number: 1858543
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2022
• 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: 39 YR
• Patient Sex: Female
• Patient Weight: 86 KG