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

Model Number	CDL-637L
Medical Device Problem Codes	Collapse (1099); 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
Based on the inspection of the retrieved m6-c, in conjunction with the clinical data, and the provided information, the device showed clear evidence of in vivo mechanical failure.The device had collapsed, the endplates were in contact, the sheath had cleaved, and the majority of the fiber construct and core initial mass were not present, which likely contributed to the observed osteolysis.Inflammation was noted, but it is unknown if infection was present.While it was not possible to determine the sequelae of events that led to the removal of this device, mechanical failure had occurred.Rmf 0003 rev 38 line 12.73.4.- resorption or osteolysis, without infection/infected abscess/infected cyst, leading to surgical intervention with explantation.Rmf 0003 rev 38 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.
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 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury dr; sunnyvale CA 94085
• Manufacturer Contact: erika wagner ; 501 mercury dr; sunnyvale, CA
• MDR Report Key: 19231385
• Report Number: 3004987282-2024-00015
• Device Sequence Number: 6016035
• 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 Expiration Date: 06/26/2018
• Device Model Number: CDL-637L
• Device Catalogue Number: FG0031-14
• Device Lot Number: H80008012
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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