MalfunctionFSZ
MAST QUADRANT RETRACTOR SYSTEM
Received May 22, 2014
Report 1030489-2014-02600 · MDR key 3828056
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
- No Known Impact Or Consequence To Patient
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
IT WAS REPORTED THAT THE LIGHT SOURCE STARING SMOKING 10 MINUTES INTO A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.