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

Model Number	CDL-637L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Headache (1880); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Fibrosis (3167)
Date of Event	04/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received states: the patient is a 64-year-old female who presents with a history of osteolysis surrounding c6/7 disc prosthesis.She also has a disc lesion at c5/6.There is evidence of fibrosis, chronic inflammation comprising predominantly lymphocytes as well as numerous macrophages.The macrophages contain metal particles in the cytoplasm which are non refractile (metallosis).There is no evidence of suppuration and no evidence of a neoplastic population.Infective organisms are not noted.The patient complained of severe headaches, left arm pain and an inability to extend her neck for about 18 months.Her sleep was affected by the pain.Clinically the patient had myelopathic signs with severe weakness in her left hand.Xrays and ct showed that the core of the m6 device at c6.7 had dissolved and there was extensive osteolysis in the surrounding vertebrae at c6.And c7.The mri showed a disc herniation at the c5.6 level with spinal cord compression and signal changes in the spinal cord.The patient had surgery on (b)(6) 2024 and the m6 device was removed at c6.7, discectomy c5.6 and c 6 corpectomy performed with fusion c5-7.
Additional Manufacturer Narrative
Product has not returned for investigation.
Additional Manufacturer Narrative
It was initially thought that this was a two level removal.Only one disc was removed from the patient and reported on report 3004987282-2024-00015.This is a correction to this report number to confirm only one device was returned for investigation.
Event or Problem Description
Information received states: the patient is a 64-year-old female who presents with a history of osteolysis surrounding c6/7 disc prosthesis.She also has a disc lesion at c5/6.There is evidence of fibrosis, chronic inflammation comprising predominantly lymphocytes as well as numerous macrophages.The macrophages contain metal particles in the cytoplasm which are non refractile (metallosis).There is no evidence of suppuration and no evidence of a neoplastic population.Infective organisms are not noted.The patient complained of severe headaches, left arm pain and an inability to extend her neck for about 18 months.Her sleep was affected by the pain.Clinically the patient had myelopathic signs with severe weakness in her left hand.Xrays and ct showed that the core of the m6 device at c6.7 had dissolved and there was extensive osteolysis in the surrounding vertebrae at c6.And c7.The mri showed a disc herniation at the c5.6 level with spinal cord compression and signal changes in the spinal cord.The patient had surgery on (b)(6) 2024 and the m6 device was removed at c6.7, discectomy c5.6 and c 6 corpectomy performed with fusion c5-7.

• Brand Name: M6-C
• Common Device Name: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury dr; sunnyvale CA
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury dr; sunnyvale CA 94085
• Manufacturer Contact: erika wagner ; 501 mercury dr; sunnyvale, CA
• MDR Report Key: 19231579
• Report Number: 3004987282-2024-00016
• Device Sequence Number: 20553685
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2024

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-637L
• Device Catalogue Number: CDL-637L
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2013
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 80 KG