MalfunctionNDF
TORNIER STAYFUSE GREAT TOE INTERPHALANGEAL IM
Received Oct 22, 2009 · Event occurred Sep 24, 2009
Report 9610667-2009-00024 · MDR key 2627503
Device
Generic name
Screw, Fixation, Bone
Manufacturer
Tornier Inc.Catalog number
STA-P4; STA-D7
Lot number
K10660; K10621
Product problems
- Disconnection
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT IS REPORTED THAT A STAYFUSE TOE JOINT PROSTHESIS DEVICE BECAME DISCONNECTED ABOUT SIX WEEKS POST IMPLANTATION AND REQUIRED A REPLACEMENT UNIT. DATE OF INITIAL IMPLANT HAS NOT YET BEEN PROVIDED. RADIOGRAPHS REQUESTED HAVE NOT YET BEEN PROVIDED. EXPLANTED DEVICE HAS BEEN RECOVERED FOR EXAMINATION. THE EXPLANTED FAILED DEVICE IS A MATED COMPONENT PAIR: STA-P4, LOT K10660, EXPIRY MARCH 2013; STA-D7, LOT K10621, EXPIRY FEBRUARY 2013. (B)(4).