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

Catalog Number CDL-637L

Device Problem Collapse (1099)

Patient Problem Insufficient Information (4580)

Event Date 04/04/2023

Event Type  Injury  

Manufacturer Narrative

The build lhr for cdl-637l h80003801 (b)(4) was examined including the final inspection records and the in-process measurements.The device met the m6-c product specification including the axial stiffness and flexural resistance specifications.A review of the risk management files revealed no new risks associated with the device.Rmf 0003 rev 36 line 12.42.- excessive height loss/disc collapse: < 1mm between endplates leading to surgical/major intervention, with explantation, involving patient with only a single level m6-c.Rmf 0003 rev 36 line 12.73.4.- resorption or osteolysis, without infection/infected abscess/infected cyst, leading to surgical intervention with explantation.

Event Description

Information provided states that patient underwent c3/4 cervical arthroplasy in 2011.Current x-rays show loss of height and adjacent lysis to the endplates of the m6-c.A revision surgery was performed to remove the device.

• 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: 16920167
• MDR Text Key: 315106382
• Report Number: 3004987282-2023-00021
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 05/12/2023

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: 10/14/2010
• Device Catalogue Number: CDL-637L
• Device Lot Number: H80003801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/14/2010
• 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