MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC X-STOP PEEK INTERSPINOUS SPACER; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

Catalog Number 1-3208

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

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994)

Event Date 07/22/2013

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2012, the patient underwent a surgery using two peek interspinous spacers at l3/l4 and l4/l5.Patient was hospitalized on (b)(6) 2012 and was discharged on (b)(6) 2012.On (b)(6) 2013, the patient underwent laminectomy as an additional surgery.Ct images (taken on (b)(6) 2013) obtained for additional surgery revealed no abnormality regarding spacer location or space between spinous processes treated.A nerve block was performed for the event.The event severity was non-serious.The event outcome was reported to be resolving on (b)(6) 2013.The physician considered the event of additional surgery as causally related to the implants.The patient was withdrawn from pms on (b)(6) 2013 due to the event onset.The physician judged the interspinous process spacers as ineffective in this patient.

Manufacturer Narrative

(b)(4) - (neurological deficit); (no known device problem).(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a revision surgery was performed and consisted of l4 laminoplasty, decompression at l3 to l5, and both interspinous processes' removal.The physician commented that re-stenosis caused worsening of pain in the lower extremity.The reason for the patient's withdrawal from pms has been changed to "due to implant removal required" from "due to the event onset".

• Brand Name: X-STOP PEEK INTERSPINOUS SPACER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinnea rd.; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4633063
• MDR Text Key: 18040180
• Report Number: 1030489-2015-00661
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1-3208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 00056 YR
• Patient Weight: 43