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

Model Number	CDL-627
Medical Device Problem Codes	Material Discolored (1170); Scratched Material (3020); Insufficient Device Problem Information (3190); Ejection Problem (4009)
Health Effect - Clinical Codes	Bacterial Infection (1735); Osteolysis (2377); Neck Pain (2433)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was -m6c revision case-- blumenthal et al (esj 2024).Discusses the outcomes and management.Strategies for patients who underwent revision or removal of cervical total disc replacements (tdr).The most common reason for removal/revision encountered in this cohort was severe osteolysis, 7 were m6-c.
Additional Manufacturer Narrative
Additional information has been requested - device has not returned for investigation.
Additional Manufacturer Narrative
Additional information has been requested - device has not returned for investigation.Upon additional information received, it was determined this complaint was associated to an ide patient (b)(6).Additional details were included in this follow up report from the completed investigation.This follow up report is submitted after the fda requested a correction be made to the initial report which identified the type of report to be both 5-day report and initial report.
Event or Problem Description
It was reported that there was -m6c revision case-- blumenthal et al (esj 2024).Discusses the outcomes and management.Strategies for patients who underwent revision or removal of cervical total disc replacements (tdr).The most common reason for removal/revision encountered in this cohort was severe osteolysis, 7 were m6-c.Additional information provided stated the reason for device explantation was due to patient neck swelling due to a cervical mass and suspected osteolysis due to infection.

• Brand Name: M6 CERVICAL
• Common Device Name: ARTIFICAL 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: 20306482
• Report Number: 3004987282-2024-00033
• Device Sequence Number: 7588548
• Product Code: MJO
• UDI-Device Identifier: 00812388030032
• UDI-Public: 00812388030032
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Five-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 54 YR
• Patient Sex: Male