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

Catalog Number	CDM-625
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved was not returned for investigation.The lhr for 9003 for (b)(6) was examined including the final inspection records and the in-process measurements.There were no ncmrs associated with this lot.The device met the m6-c product specification including the axial stiffness and flexural resistance specifications.Risk mamagement files were reviewd and no new riks were identified.Rmf 0003 rev 38 line 15 - failure to relieve symptoms including unresolved pain.Rmf 0003 rev 38 line 12.75 - device explanted.
Event or Problem Description
Information provided states that patient had m6-c implanted at level c5/6 in (b)(6) 2019.Patient began experiencing pain 4 years post implanting.The total disc replacement was explanted and replaced with acdf in (b)(6) 2023.

• Brand Name: M6-C
• Common Device Name: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury drive; sunnyvale 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury drive; sunnyvale 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale 94085
• MDR Report Key: 18567962
• Report Number: 3004987282-2023-00071
• Device Sequence Number: 8518006
• Product Code: MJO
• UDI-Device Identifier: 00812388030018
• UDI-Public: 00812388030018
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2024

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: 11/30/2022
• Device Catalogue Number: CDM-625
• Device Lot Number: 9003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2023
• Initial Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2017
• 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: 37 YR
• Patient Sex: Female