MAUDE Adverse Event Report: MDT KYPHON SUNNYVALE MFG X-STOP PEEK INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Catalog Number 1-3210

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 05/13/2011

Event Type  Injury  

Event Description

It was reported that a patient with lumbar spinal canal stenosis underwent a decompression procedure at levels l3/l4 and l4/l5 using interspinous spacers.The patient's hospitalization was prolonged due to implant migration at l4/5 and a re-implantation surgery.One year postoperatively, the patient complained of mild pain in the back, hip and legs (felt at least once a day).Approximately 40 months post-op, the patient reportedly "fell and felt a severe pain".Seven days later, the patient was emergently admitted to the hospital.X-ray and ct examinations did not confirm abnormality with implant positioning.A removal surgery for all the implants and decompression (laminectomy) was performed six days after admission into the hospital.As of the same day, the outcome was reported as ¿resolved.¿ no other additional treatment was given.The surgeon commented that the patient had been diagnosed with severe stenosis and external force of falling might have induced the pain.

Manufacturer Narrative

(b)(4).

• Brand Name: X-STOP PEEK INTERSPINOUS SPACER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): MDT KYPHON SUNNYVALE MFG; 1221 crossman ave.; sunnyvale CA 94089
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4248282
• MDR Text Key: 4992144
• Report Number: 2953769-2014-00138
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2014

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: Health Professional
• Device Expiration Date: 10/04/2012
• Device Catalogue Number: 1-3210
• Device Lot Number: 2232391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2014
• Initial Date FDA Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2010
• 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): Required Intervention
• Patient Age: 00080 YR
• Patient Weight: 83