MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC 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 Problems Neurological Deficit/Dysfunction (1982); Pain (1994)

Event Date 05/21/2014

Event Type  Injury  

Event Description

It was reported that a patient underwent a spinal decompression surgery using an interspinous spacer.The levels treated were l3-l4, l4-l5.According to the report, sometime post-op "the patient began suffering from increased pain in right buttock down back of right thigh to ball of foot as well as advent of left anterior groin pain radiating 6 inches down thigh".The pain is unresolved at this time and an unknown form of medical intervention was administered.No further information was reported.

Manufacturer Narrative

(b)(4).Unknown devices of multiple part/lot numbers were implanted during the procedure including: part: 1-3210 / lot: 2324242, part: 1-3210 / lot: rm13l001 although it is unknown which of these 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: 4009342
• MDR Text Key: 4705134
• Report Number: 1030489-2014-03445
• 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: 07/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2015
• Device Catalogue Number: 1-3210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2013
• 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: 00064 YR
• Patient Weight: 74