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

Catalog Number CDL-627

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2024

Event Type  Injury  

Manufacturer Narrative

The devices have been received for evaluation.Additional information has been requested regarding reason for removal.

Event 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.

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 Description

Product was returned and investigation completed.

• Brand Name: M6-C
• Type of Device: 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
• MDR Text Key: 335528456
• Report Number: 3004987282-2024-00001
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female