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

Model Number 6LL

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/02/2023

Event Type  Injury  

Manufacturer Narrative

The build lhr for cdl-637l 1675939 aev885 was examined including the final inspection records and the in-process measurements.There was no ncmr associated with this lot.The device met the m6-c product specification including the axial stiffness and flexural resistance specifications.A review of the risk management files ws performed resulting in no new risks identified.Rmf 0003 rev 36 line 12.75 - device explanted.Additional details of the event have been requested.

Event Description

Information provided states that an m6-c artificial cervical disc implanted in 2021 was removed.The reason for the removal is unknown at this time.

• 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 ; 2149372015
• MDR Report Key: 17014320
• MDR Text Key: 316051476
• Report Number: 3004987282-2023-00025
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00812388030049
• UDI-Public: 00812388030049
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2023

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 Model Number: 6LL
• Device Catalogue Number: CDL-637L
• Device Lot Number: 1675939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2023
• Initial Date FDA Received: 05/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2021
• 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 Age: 30 YR
• Patient Sex: Male