D
Patient 1
DURING A SINUS PROCEDURE (LANDMARX IMAGE GUIDED FESS), THE JAW BROKE. THE JAW PIECE AND FORCEPS WERE COLLECTED FOR RETURN TO MANUFACTURER. THERE WAS NO PT CONSEQUENCE.
MAUDE MDR 1547910
- MDR report key
- 1547910
- Report number
- 1418479-2009-00017
- Event key
- 0
- Event type
- 3
- Date of event
- 2009-10-07
- Date received
- 2009-11-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ELEANOR HALL
- Address
- 353 CORPORATE WOODS PKWY. VERNON HILLS IL 60061 US
- Phone
- 847-847-8479
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ETHMOID FORCEPS STRAIGHT | ETHMOID FORCEPS STRAIGHT | RICHARD WOLF GMBH | JXX | 8211.09 | 8211.09 | UNK | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-11-20 | 0 |
Event Narratives#
N
Patient 1
EVALUATION SUMMARY: 8211.09 - ETHMOID FORCEPS STRAIGHT - LOT #: UNK. THE ETHMOID FORCEPS WERE INSPECTED AND BROKEN JAW WAS CONFIRMED. THE BROKEN JAW WAS NOT INCLUDED IN THE RETURNED PACKAGE. WE DO NOT KNOW IF IT WAS DISCARDED WITHIN OUR FACILITY, OR AT THE USER FACILITY. THE ETHMOID FORCEPS IS, FROM APPEARANCE, 10 PLUS YEARS OLD. THE ETHMOID FORCEPS ARE DESIGNED TO GRASP, NOT CUT TISSUE. THE TISSUE IS REMOVED BY GRASPING AND PULLING IT GENTLY AWAY FROM THE MUSCOSA OR BONE. CAUSE: USE AND HANDLING WITH EXCESS FORCE APPLIED TO THE JAW DURING USE.