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

Model Number M6-C 6MM LARGE LONG

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

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930); Neck Pain (2433)

Event Date 02/13/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history records for this device did not reveal any non-conformances.The discs are not available for return or evaluation.Additional information has been requested.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

It was reported that an m6-c artificial disc was implanted in 2010 at c6/7 and another m6-c was implanted (b)(6) 2013 at c5/6.The patient had pain since 6 months with tingling sensation and both discs were removed.

Manufacturer Narrative

No devices were returned thus no device examination could be performed.It was noted that all discs were intact and solidly connected to the vertebral bodies.The presence of staph.Epidermidis was detected.Based on the limited information provided, it was not possible to ascertain the relationship between these factors and the explantation.This is one (1) of two (2) reports.

• 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: 8541321
• MDR Text Key: 142803989
• Report Number: 3004987282-2019-00007
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• 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: M6-C 6MM LARGE LONG
• Device Catalogue Number: CDL-637L
• Device Lot Number: H80007733
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 92