MAUDE Adverse Event Report: KYPHON SARL X-STOP 14MM; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Lot Number 070214

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/03/2007

Event Type  Injury  

Event Description

I was on caudal epidural injections for 4 years prior to this event, it came to light that i had an anterior slip.It was recommended in 2006 that i had a full fixation of my l5/l4 /l3.The hospital was taken over by a trust they stopped this procedure cost cutting, i was then in all there wisdom fitted with an x stop device on (b)(6) 2007.(b)(4), size 14 mm, lot: 070214.After 4 months, it broke apart causing me to be bedridden and had several painkilling injections.As an emergency, it was taken out.I was put on morphine which i am still on today.Please could you give me any information as to this part number and also what type or period of training a surgeon would have to undergo to fit the xstop device.Any device would be greatly appreciated.Regards, (b)(6).Dates of use: (b)(6) 2007- (b)(6) 2007.Diagnosis or reason for use: spinal fusion.

• Brand Name: X-STOP 14MM
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): KYPHON SARL; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 8129038
• MDR Text Key: 129461061
• Report Number: MW5081805
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/30/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2007
• Device Lot Number: 070214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 67 YR
• Patient Weight: 75