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

Catalog Number	CDL-727
Medical Device Problem Codes	Collapse (1099); Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved was not returned for analysis.A review of the lot history records and radigraphic images are pending.A review of the risk management files was performed and no new risks were identified.Rmf 0003 rev 36 line 12.46.- excessive height loss/disc collapse: < 1mm between endplates not leading to surgical/major intervention, involving patient an unknown number of cervical spinal implants 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 that had m6-c implanted at c5/6 & c6/7 in (b)(6) 2016.During a control appointment lysis was seen on the x-ray and disc height reduction on the m6-c at the c5/6 level.The patient had no symptoms.

• 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
• MDR Report Key: 17695659
• Report Number: 3004987282-2023-00055
• Device Sequence Number: 14102985
• Product Code: MJO
• UDI-Device Identifier: 00812388030070
• UDI-Public: 00812388030070
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/06/2023

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 Expiration Date: 04/30/2017
• Device Catalogue Number: CDL-727
• Device Lot Number: H80006463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2012
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 90 KG