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

Model Number	CDL-637L
Medical Device Problem Codes	Mechanical Problem (1384); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Granuloma (1876); Osteolysis (2377)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Rmf 0003 rev 39 line 12.73.1.- resorption or osteolysis, with known or suspected infection/infected abscess/infected cyst, leading to surgical intervention with explantation.Rmf 0003 rev 39 line 12.75 - device explanted.
Event or Problem Description
It was reported: op: c4/5 tdr (pro-disc) + replacement (revision) of c5/6+c6/7 m6c - replacing with prism borealis auilia acdf implants.Osteolysis diagnosis and mechanical failure of the prosthesis on both levels c5/6+ c6/7.Implantation time frame 1st - (estimate year- 2015) c6/7 - implanted in wa 2nd - (estimate year- 2017) c5/6 - implanted by j.Papacostas - qld.Findings during removal -found a big granuloma in front of c5/6.Sample taken and sent to pathology ( c5/6 granulation tissue).Removed c6/7 first (in parts) followed by c 5/6.(intact implant).
Additional Manufacturer Narrative
Rmf 0003 rev 39 line 12.73.1.- resorption or osteolysis, with known or suspected infection/infected abscess/infected cyst, leading to surgical intervention with explantation.Rmf 0003 rev 39 line 12.75 - device explanted.Based on the inspection of the retrieved m6-c, in the absence of clinical data, radiographs, or radiographic analysis, the cause of this event was unclear.The endplates and sheath were intact, though a loss of retention was noted.Further, in vivo damage to the fiber construct was visible, though it could not be fully inspected.The core appeared to be present between the endplates, as they were not in contact.While it is clear that in vivo damage had occurred, destructive analysis is necessary to inspect the fiber construct and the core to determine if mechanical failure had occurred.It is unknown if infection was suspected or confirmed, which may have contributed to the reported osteolysis.Further, the patient had an additional device at an adjacent level (pe 24-52-b) which may have contributed to the removal of this device.Therefore, the failure of this procedure and the removal of this device was not clear, particularly in the absence of additional clinical information or radiographs.
Event or Problem Description
It was reported: op: c4/5 tdr (pro-disc) + replacement (revision) of c5/6+c6/7 m6c - replacing with prism borealis auilia acdf implants.Osteolysis diagnosis and mechanical failure of the prosthesis on both levels c5/6+ c6/7.Implantation time frame 1st - (estimate year- 2015) c6/7 - implanted in (b)(6).2nd - (estimate year- 2017) c5/6 - implanted by (b)(6).Findings during removal -found a big granuloma in front of c5/6.Sample taken and sent to pathology (c5/6 granulation tissue).Removed c6/7 first (in parts) followed by c 5/6 (intact implant).

• 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: 20592434
• Report Number: 3004987282-2024-00041
• Device Sequence Number: 20470644
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2024

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: 05/01/2022
• Device Model Number: CDL-637L
• Device Catalogue Number: FG0031-14
• Device Lot Number: 8132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (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: Male
• Patient Weight: 103 KG