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

Model Number 6MM LARGE

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Osteolysis (2377); Neck Pain (2433)

Event Date 11/23/2020

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested.A review of the lot history records for this device did not reveal any non-conformance's to specification or deviations in procedure.This was a two-level implantation.In the us, the m6-c artificial cervical disc is indicated only in patients with disease at one level from c3-c7.The safety and effectiveness of the m6-c artificial cervical disc has not been established in patients with more than one cervical level requiring surgery.This is one (1) of two (2) reports submitted on this event.

Event Description

Patient with two m6-c devices presented with pain.The device was implanted at index level c5/6 and was in vivo for 77 months in a (b)(6) female patient.The device was explanted.The condition of the device at the time of removal is unknown.

Manufacturer Narrative

B4: 12-jun-2021.D8: no.G3: 09-jun-2021.G6: follow-up # 1.H2: additional information.H6: health effect - clinical: 2433.Medical device problem code: 2682.Type of investigation: 3331.H10: the device was not returned, thus device examination could not be performed.This report is made by the manufacturer without prejudice and does not imply an admission of liability for the incident or its consequences.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale CA 94085
• MDR Report Key: 10972502
• MDR Text Key: 220416131
• Report Number: 3004987282-2020-00104
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Model Number: 6MM LARGE
• Device Catalogue Number: CDM-635L
• Device Lot Number: H80007786
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR