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

Model Number 6LL

Device Problem Insufficient Information (3190)

Patient Problems Inadequate Pain Relief (2388); Insufficient Information (4580)

Event Date 01/12/2023

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested.A review of the build lot history records 8683 for cdl-637l s/n (b)(4).Iwere exaqmined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with these lots.The devices met the m6-c product specifications including the axial stiffness and flexural resistance specirfications.Risk management files were reviewed and no new risks were identified.

Event Description

Information provided states that patient had m6-cs implanted at c4/5, c5/6 and c6/7 at an unknown time.No "additional" information has been provided regarding reason for explanting of the three devices.

Manufacturer Narrative

Additional information has been requested.A review of the build lot history records 8683 for cdl-637l s/n (b)(6) were examined including the final inspection records and the in-process measurements.There were no relevant ncmrs associated with these lots.The devices met the m6-c product specifications including the axial stiffness and flexural resistance specifications.Risk management files were reviewed and no new risks were identified.Based on the inspection of the retrieved m6-cs, in the absence of additional clinical data, radiographs, or radiographic analysis, the cause of this event was unclear.It is unknown if infection was suspected or confirmed.While some in vivo damage was noted on the cores, the majority of the damage appeared to be extraction damage.Due to the extent of the extraction damage and lack of additional clinical or radiographic information, it is unclear if the devices at c4/5 and c5/6 had failed mechanically at the time of removal.The device at c6/7 was grossly intact, indicating this device had likely not failed at the time of removal.The failure of this procedure and the removal of these devices was not clear.

Event Description

Information provided states that patient had m6-cs implanted at c4/5, c5/6 and c6/7 at an unknown time.On (b)(6) 2023 three m6-cs were removed due to unresolved pain.

• Brand Name: M6-C
• Type of Device: ARTIFICIAL CERVICAL DISC
• Manufacturer (Section D): SPINAL KINETICS; 501 mercury drive; sunnyvale CA 94085
• Manufacturer (Section G): SPINAL KINETICS; 501 mercury drive; sunnyvale CA 94085
• Manufacturer Contact: ehab esmail ; 501 mercury drive; sunnyvale, CA 94085
• MDR Report Key: 16616616
• MDR Text Key: 312010678
• Report Number: 3004987282-2023-00007
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2022
• Device Model Number: 6LL
• Device Catalogue Number: CDL-637L
• Device Lot Number: 8683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• 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): Other
• Patient Sex: Male