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

Model Number 6M

Device Problems Collapse (1099); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/29/2023

Event Type  Injury  

Manufacturer Narrative

The build lhr for h80008060 abh009 and h80007539 abe440 was 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 specification including the axial stiffness and flexural resistance specifications.Risk management file review identified no new risks associated with the device.Rmf 0003 rev 36 line 12.45.- excessive height loss/disc collapse: < 1mm between endplates leading to surgical intervention, with explantation, involving patient with multiple cervical spinal implants.Rmf 0003 rev 36 line 12.75 - device explanted.

Event Description

Information provided states that a revision surgery was performed to remove two collapsed m6-c discs that were implanted 12/13 years ago.No additional information has been forthcoming.

Manufacturer Narrative

The build lhr for h80008060 abh009 and h80007539 abe440 was 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 specification including the axial stiffness and flexural resistance specifications.Risk management file review identified no new risks associated with the device.Rmf 0003 rev 36 line 12.45.- excessive height loss/disc collapse: < 1mm between endplates leading to surgical intervention, with explantation, involving patient with multiple cervical spinal implants.Rmf 0003 rev 36 line 12.75 - device explanted.Based on the inspection of the retrieved m6-c, in conjunction with the clinical data, and the provided radiographic images, the devices showed clear evidence of in vivo mechanical failure after the reported 12-13 years.The devices had collapsed, the sheaths had cleaved, and the endplates at c5/6 were no longer attached to each other and c6-7 endplates were only loosely attached.Furthermore, there was evidence of abrasive contact between the endplates.Without interim radiographs, it was not possible to determine the sequelae of events that led to the failure of this pe.

Event Description

Information provided states that a revision surgery was performed to remove two collapsed m6-c discs that were implanted 12/13 years ago.No additional information has been forthcoming.Additional information states that the tw m6-c discs were implanted at c5/6 and c6/7.

• 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: 16850881
• MDR Text Key: 314369996
• Report Number: 3004987282-2023-00018
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00812388030018
• UDI-Public: 00812388030018
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P170036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

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 Expiration Date: 07/31/2018
• Device Model Number: 6M
• Device Catalogue Number: CDM-625
• Device Lot Number: H80008060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2023
• 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: 52 YR
• Patient Sex: Female