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

Catalog Number 1-3210

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/06/2014

Event Type  Injury  

Event Description

It was reported a patient who received l4-l5 interspinous spacer implant underwent a revision surgery approximately 18 months post-op to have the device removed.According to the report, the patient underwent an explant, lumbar decompression and spinal fusion during the revision.No further information is available at this time.

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: 3648070
• MDR Text Key: 4348155
• Report Number: 2953769-2014-00024
• 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: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• 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
• Date Manufacturer Received: 01/28/2014
• 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: 00062 YR
• Patient Weight: 103