D
Patient 1
ALLEGEDLY, WHILST USING THE DRILL THE COIL OF THE INSTRUMENT UNRAVELED MAKING THE INSTRUMENTS UNUSABLE. THE SURGERY WAS EXTENDED GREATER THAN 30 MINUTES.
MAUDE MDR 4851765
- MDR report key
- 4851765
- Report number
- 3010536692-2015-01323
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-05-18
- Date received
- 2015-06-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Address
- 5677 AIRLINE ROAD ARLINGTON TN 38002 US
- Phone
- 901-901-9018
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | FLEXIBLE DRILL SCREW SHAFT MODULAR | HIP INSTRUMENT | MICROPORT ORTHOPEDICS INC. | KWB | 8400-FD01 | NI | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-17 | 0 | 1. R |
Event Narratives#
N
Patient 1
THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2015-01324.
N
Patient 1
THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.