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 Pain (1994); Stenosis (2263)

Event Date 05/01/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent an interspinous process decompression at levels l3-l4, l4-l5.Five months post-op, the patient reported progressive low back and right posterior thigh and leg pain for five months.The mri revealed progressive lumbar spondylotic changes with severe canal stenosis at l3-l4 and l4-l5 and spondylolisthesis at l4-l5.The patient underwent a removal at l3-l4 and l4-l5 and decompressive laminectomies and foraminotomies with in situ fusion at l3-l4 and l3-l5.The interspinous spacer devices were explanted on (b)(6) 2014.The investigator noted this event was serious with a severity of moderate.The relationship to the device was not related.The outcome of the event is resolved.

Manufacturer Narrative

(b)(4).Unknown although it is unknown if any medtronic devices contributed to the reported event, we are filing this mdr for notification purposes.

• 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: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4365421
• MDR Text Key: 21769193
• Report Number: 1030489-2014-04862
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2014

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: 03/31/2010
• Device Catalogue Number: 1-3208
• Device Lot Number: 2087041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2008
• 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: 00071 YR
• Patient Weight: 107