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

Catalog Number	CDL-627
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices have been received for evaluation.Additional information has been requested regarding reason for removal.
Event or Problem Description
Information provided states that patient had m6-c's, artificial cervical disc, implanted at levels c5/6 - c6/7 at an unknown time.The two devices were explanted in (b)(6) 2024 due to unknown reasons.No additional information has been provided at this time.
Additional Manufacturer Narrative
The build lhr was examined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with this lot.The devices met the m6-c product specification including the axial stiffness and flexural resistance specifications.Rmf 0003 rev 38 line 12.75 - device explanted.Based on the inspection of the retrieved m6-c, the device did not show evidence of mechanical failure.Some in vivo damage was observed, including fraying of the fiber and a partial loss of furrows and abrasive damage to the core, however, inspection of all components, indicates that the device was likely intact at the time of removal.However, the lack of clinical data, radiographic analysis, and microbiological and histopathological analysis inhibits the further interpretation of the mechanism of failure of this device in this patient.
Event or Problem Description
Product was returned and investigation completed.

• Brand Name: M6-C
• Common Device Name: ARTIFICIAL CERFICAL 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: 18718233
• Report Number: 3004987282-2024-00001
• Device Sequence Number: 20462373
• Product Code: MJO
• UDI-Device Identifier: 00812388030032
• UDI-Public: 00812388030032
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P170036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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 Expiration Date: 09/11/2019
• Device Catalogue Number: CDL-627
• Device Lot Number: 3882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2014
• 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: 67 YR
• Patient Sex: Female