MAUDE Adverse Event Report: SPINE WAVE, INC. STAXX XD; SPINAL VERTEBRAL BODY REPLACEMENT

Device Problems Loose or Intermittent Connection (1371); Material Protrusion/Extrusion (2979)

Patient Problem Pain (1994)

Event Date 05/28/2014

Event Type  Injury  

Event Description

It was reported that the patient presented with back pain and radiculopathy at approximately 14 months post operatively.A reoperation was performed to remove the implants at which time a tear to the dura was noted in the location where a portion of the implant was loosened from the construct and sticking out.

Manufacturer Narrative

Device not available for evaluation.

• Brand Name: STAXX XD
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT
• Manufacturer (Section D): SPINE WAVE, INC.; shelton CT
• Manufacturer Contact: ronald smith ; 3 enterprise drive; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 3911580
• MDR Text Key: 21967973
• Report Number: 3004638600-2014-00004
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention