MAUDE Adverse Event Report: INTEGRA BURLINGTON, MS, INC ULTRALITE PRO MODULE

Catalog Number 001380LX

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2014

Event Type  malfunction  

Event Description

The closest linkage in the module connection fell off while the surgeon was operating during a spinal fusion.The link fell onto the drape and the scrub covered it with an impervious drape.No harm done to pt.Two minute delay.

Manufacturer Narrative

To date the device involved in the reported incident has not been received for eval.An investigation has been initiated based on the reported info.

• Brand Name: ULTRALITE PRO MODULE
• Type of Device: NA
• Manufacturer (Section D): INTEGRA BURLINGTON, MS, INC; burlington MA 01803
• Manufacturer Contact: sandra lee ; 315 enterprise dr; 6099366828
• MDR Report Key: 4110537
• MDR Text Key: 4758841
• Report Number: 1222895-2014-00024
• Device Sequence Number: 1
• Product Code: FST
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K864380
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 001380LX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1