MAUDE Adverse Event Report: SPINEOLOGY, INC. SPINEOLOGY OPTIMESH TRAY; 6.5MM SHAPER

Model Number 3110042

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2014

Event Type  Injury  

Event Description

During set-up in operating room for a minimally invasive spine procedure, debris was found on operating room table.Debris came out of an instrument from a vendor loaned set.Room was cleaned.New supplies and instrumentation was obtained.The three pieces of equipment were removed from service and returned to vendor since it was loaned equipment.Another tray was set up for the case that did not have any visible debris.As part of investigation, a sterile tray was examined and debris was found after manipulating the equipment.This may be a problem with the design of the equipment that will not allow you to take it apart.

• Brand Name: SPINEOLOGY OPTIMESH TRAY
• Type of Device: 6.5MM SHAPER
• Manufacturer (Section D): SPINEOLOGY, INC.; 7800 3rd street north; ste. 600; st paul MN 55128 545
• MDR Report Key: 3603245
• MDR Text Key: 4071010
• Report Number: MW5034122
• Device Sequence Number: 3
• Product Code: GZX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/24/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3110042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention