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

Model Number	6ML
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Numbness (2415); Neck Pain (2433)
Date of Event	10/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.Additional information has not been provided to identify the s/n of the device involved in this case therefore a review of the lot history records could not be performed.A review of the risk management files did not result in any new risks associated with the device.Rmf 0003 rev 36 line 12.73.4.- resorption or osteolysis, without infection/infected abscess/infected cyst, leading to surgical intervention with explantation.Rmf 0003 rev 36 line 12.75- device explanted.
Event or Problem Description
Information provided states patient involved in accident in (b)(6) 2015.In (b)(6) 2016 patient exp neck and shoulder pain.Patient had m6-c implanted at c5/6 in (b)(6) 2016.Patient experienced neck/back pain, headaches numbness/tingling.Patient underwent removal of the m6-c disc and cervical spine fusion in (b)(6) 2022.

• Brand Name: M6-C
• Common Device Name: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury drive; sunnyvale CA 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury drive; sunnyvale CA 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale, CA 94085 ; 2149372015
• MDR Report Key: 17373538
• Report Number: 3004987282-2023-00039
• Device Sequence Number: 17901364
• Product Code: MJO
• UDI-Device Identifier: 00812388030025
• UDI-Public: 00812388030025
• 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: 2016
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/20/2023

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: 6ML
• Device Catalogue Number: CDM-635L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2023
• Initial Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 42 YR
• Patient Sex: Male