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

Model Number	CDL-637L
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Granuloma (1876); Osteolysis (2377)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
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).
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.
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 compiled in the present report, in the absence of additional clinical data, radiographs, or radiographic analysis, the cause of this event was unclear.While some in vivo damage was noted, the device was reported to have been intact at the time of removal.Due to the extent of the extraction damage and lack of additional clinical or radiographic information, it is unclear if this device had failed mechanically at the time of removal; however, device collapse was not evident.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-a) 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: 20592263
• Report Number: 3004987282-2024-00042
• Device Sequence Number: 21031880
• 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: 2017
• 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 Model Number: CDL-637L
• Device Catalogue Number: FG0031-14
• Device Lot Number: 2271
• 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
• Date Device Manufactured: 05/01/2014
• 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: Male
• Patient Weight: 103 KG