D
Patient 1
USER FACILITY REPORTS DURING LUMBAR DECOMPRESSION PROCEDURE; MOVEABLE JAW BROKE OFF IN WOUND. THE BROKEN PORTION WAS REMOVED; HOWEVER, ADD'L OR TIME OF ABOUT 1 HOUR WAS ADDED TO THE CASE AS A RESULT.
MAUDE MDR 290610
- MDR report key
- 290610
- Report number
- 1226348-2000-00042
- Event key
- 0
- Event type
- 3
- Date received
- 2000-08-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MATTHEW KING
- Address
- 325 PARAMOUNT DR RAYNHAM MA 02767 US
- Phone
- 508-508-5080
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DECKER MICRO RONGEUR | RONGEUR, MANUAL | CODMAN & SHURTLEFF, INC. | HAE | NA | 53-4000 | 001 | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2000-08-15 | 0 | 1. O |