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 Pain (1994); Stenosis (2263)

Event Date 04/15/2016

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported that a patient with spacer at l3-l4.On (b)(6) 2016, post-op, leg pain again started and pressure on the dural tube due to thickened ligamentum flavum had not been eliminated.Symptoms of lumbar spinal canal stenosis returned after implantation of the product, indicating a worsening of stenosis.As a result, laminectomy was performed.As per doctor revision surgery was unavoidable.Product came in contact with the patient.

Event Description

Laminectomy at l3-4 was performed on (b)(6) 2016.The patient's symptom temporally recovered after laminectomy but it recurred even though any spacer associated problem like migration was not noted.Therefore the surgeon determined the event was due to the patient-specific factor and was causality not related to spacer.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: X-STOP PEEK INTERSPINOUS SPACER
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 5747607
• MDR Text Key: 48094265
• Report Number: 1030489-2016-01891
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2016

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: 02/07/2013
• Device Catalogue Number: 1-3210
• Device Lot Number: 2245341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2016
• Initial Date FDA Received: 06/24/2016
• Supplement Dates Manufacturer Received: Not provided; 06/09/2016
• Supplement Dates FDA Received: 07/07/2016; 09/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2011
• 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: 62 YR
• Patient Weight: 83