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

Model Number 6MM MEDIUM

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Paresis (1998); Neck Pain (2433)

Event Date 04/29/2021

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-conformances to specification or deviations in procedure.The risk management files were reviewed and no new risks were identified in the available reported information for this pe that require any changes to the current fmea, risk analysis, or labeling.This was a two-level implantation.This is one (1) of two (2) reports submitted on this event.

Event Description

Two-level patient presented with neck pain, pain in the left shoulder and slight paresis.It was reported an instability of the prosthesis at c5/6 was assumed and a revision was performed in 2017; a second revision was performed 29 apr 2021 due to an alleged malfunction and space-occupying ossification.Both devices were explanted.The devices were intact at the time of removal.

Manufacturer Narrative

Corrected data: d4: serial number: (b)(6).G1: mr.(b)(4).This is one (1) of two (2) reports submitted on this event.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale 94085
• Manufacturer (Section G): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale CA 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale, CA 94085
• MDR Report Key: 12562842
• MDR Text Key: 274290787
• Report Number: 3004987282-2021-00042
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Model Number: 6MM MEDIUM
• Device Catalogue Number: CDM-625
• Device Lot Number: 4981
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2015
• 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): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female