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

Model Number 6MM LARGE LONG

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

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

Event Date 04/23/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history records for this device did not reveal any non-conformances.Additional information has been requested.

Event Description

It was reported that the m6-c was removed at the patient's request due to pain and after a second opinion from another physician with suspected low-grade infection.

Manufacturer Narrative

B4: 11-may-2021.D5: patient/consumer.D8: no.G1: mr.(b)(6).G2: company representative.G3: 11-may-2021.G6: follow-up # 1.H2: additional information, device evaluation.H3: yes.H6: health effect - clinical: 1930.Health effect - impact: 4627.Medical device product code: 2682.Type of investigation: 10, 3331.Investigation findings: 140.Investigation conclusions: 4315.H10: it was reported that the patient revised due to pain 1.5 years after implantation.The radiographic images were reviewed and show the implant to be undersized.In addition, there appears to be bone spur growth at c6/c7 both anterior and posterior the implant.Lack of pre-op, immediate post-op, interim timepoint, or flexion/extension images hindered further interpretation.The implant was not intact as-received.The device showed no evidence of mechanical failure.According to the provided information, the device was removed for pain and suspected infection and was attached to the vertebral bone and had to be destroyed to be removed.It was noted that tissue samples were taken for histological analysis and microbiological culture; however, no results were provided and it was not clear if infection was confirmed and contributed to, or was the cause of the failure of this procedure.

• 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: 8624935
• MDR Text Key: 145540015
• Report Number: 3004987282-2019-00016
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2022
• Device Model Number: 6MM LARGE LONG
• Device Catalogue Number: CDL-637L
• Device Lot Number: 7972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR