MAST QUADRANT RETRACTOR SYSTEM
Received May 22, 2014 · Event occurred Apr 8, 2014
Report 1030489-2014-02599 · MDR key 3827710
Device
Generic name
Light, Surgical, Carrier
Manufacturer
Medtronic Sofamor Danek Usa, IncModel number
NACatalog number
9560658
Lot number
UNK
Product problems
- Unintended Magnet Quench
Patient
Not reported
- Burn(s)
Narrative
Additional Manufacturer Narrative
(B)(4): NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION; THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.
Description of Event or Problem
A PATIENT UNDERWENT AN OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AT L1-L4. IT WAS REPORTED THAT DURING THE OPERATION, THE DEVICE BECAME HOT AND THAT HEAT WAS SUBSEQUENTLY TRANSFERRED TO THE PATIENT¿S SKIN THROUGH A RETRACTOR FRAME. THE PATIENT WAS REPORTEDLY PRESENTED WITH LOW TEMPERATURE BURN WITH BLISTERS. THE SURGICAL TIME WAS NOT EXTENDED DUE TO THE INCIDENT.