InjuryFSH
ALGEA THERAPIES
Received Feb 9, 2016 · Event occurred Feb 2, 2016
Report 5450350 · MDR key 5450350
Device
Generic name
Affirm Access Pack, Ultra, Tray
Manufacturer
Globus Medical, Inc.Model number
REF 658.902S.1Lot number
LN002260
Product problems
- Fracture
Patient
67 YR
- No Information
- No Information
Narrative
Description of Event or Problem
A (B)(6) MALE UNDERGOING A MINIMALLY INVASIVE APPROACH CLAUDICATION OF L4-L5 AND DURING THE USE OF THE JAMSHIDI NEEDLE WAS BEING USED AND BROKE OFF INTO MULTIPLE PIECES. AT THIS POINT THE CASE WAS CONVERTED TO OPEN AND FLUORO WAS USED TO LOCATE ALL THE PIECES OF THE FRACTURED NEEDLE.