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 Problem Insufficient Information (4580)

Event Date 11/08/2021

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.

Event Description

Patient presented with swallowing problems.The surgeon noted a collection of fluid anterior to the implant.The device was explanted.The condition of the device at the time of removal is unknown.

Manufacturer Narrative

Additional information provided: patient age, sex, date of birth, weight, other relevant history and implantation date.Microbiology and radiographic images have been requested.

Manufacturer Narrative

Additional information received states:.The device was intact at the time of removal with no obvious deficiency on the m6 device itself.Inflammation was noted and infection was suspected, with anterior fluid collection (mass) was noted as cause of removal.The provided information indicated that the device was intact in situ and damaged during removal.The mechanical damage suggests that force was required to remove it, and that the device was fixed at the time of removal.The posterior fiber construct was largely intact; however, some in vivo fraying was visible through the horizontal tear in the sheath.Due to the extent of the extraction damage, it was not possible to clearly assess the in vivo condition of the fiber construct.Approximately 65% of the core was not present due to removal, however some invivo damage was still visible including imprints of the pockets, loss of furrows and some light abrasive damage on the superior and inferior surfaces.Radiographs were available for the pre-operative and first 6 post-operative months.Spinalkinetics' medical advisor reviewed the images and noted that the device appeared to be appropriately sized and positioned.No interim radiographs beyond that period or prior to revision at 77 months were available; however radiolucent lines were noted as early as the first available post operative images.Based on the inspection of the retrieved m6-c, the cause of this event was unclear.The device was heavily damaged during removal; however, the extent of the damage likely indicates that it was both fixed and intact at the time of removal, as reported, suggesting that the device had not failed at the time of removal.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS LLC; 501 mercury drive; sunnyvale CA 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: 12849792
• MDR Text Key: 281086843
• Report Number: 3004987282-2021-00058
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Model Number: 6MM LARGE LONG
• Device Catalogue Number: CDL-637L
• Device Lot Number: 2363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/12/2014
• 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: Male
• Patient Weight: 93 KG