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

Model Number 6MM LARGE LONG

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)

Patient Problem Neck Pain (2433)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

Without a lot number, the device history records review could not be completed.Additional information and the return of the device has been requested.This was a two-level implantation.In the us, the m6-c artificial cervical disc is indicated for use following a single level discectomy in skeletally mature patients with intractable degenerative cervical radiculopathy with or without spinal cord compression at one level from c3 - c7.The ifu states that 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 a two-level patient was revised due to pain.Both m6-c artificial cervical discs were removed.

Manufacturer Narrative

A review of the lot history records for this device did not reveal any non-conformances to specification or deviations in procedure.Additional information has been requested.

Manufacturer Narrative

B3: 05-nov-2019.B4: 10-may-2021.D6a: 26-sep-2012.D8: no.G1: mr.(b)(6).G3: 10-may-2021.G6: follow-up # 2.H2: correction, additional information, device evaluation.H3: yes.H6: health effect - impact code: 4627.Medical device problem code: 2017.Type of investigation: 10, 3331.Investigation findings: 140.Investigation conclusions: 4315.H10: limited information was provided, notably no pre-operative, post-operative, or interim radiographs were available.Radiographs reviewed and loss of height and periprosthetic osteolysis is visible.The implant was not intact as-received.It was noted that inflammation or infection were not suspected and tissue samples were not collected during revision.The device showed evidence of mechanical damage.

• 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: 9419433
• MDR Text Key: 189003277
• Report Number: 3004987282-2019-00050
• 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,Followup
• Report Date: 05/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2017
• Device Model Number: 6MM LARGE LONG
• Device Catalogue Number: CDL-637L
• Device Lot Number: H80006277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 72