FDA Adverse Event
Injury
Summary report: N
AOS TROCHANTERIC NAIL
MDR report key: 1910706
·
Received November 22, 2010
Report
- Report Number
- 2032480-2010-00008
- Event Type
- Injury
- Date Received
- November 22, 2010
- Date of Event
- October 22, 2010
- Report Date
- November 22, 2010
- Manufacturer
- ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Product Code
- HSB
- PMA / PMN Number
- K021008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
ON (B)(6), 2010, THE PT WAS IMPLANTED WITH AN AOS 11MM X 30CM ES TROCHANTERIC NAIL. DURING THE SURGERY, THE NAIL BROKE THROUGH THE ANTERIOR CORTEX IN THE DISTAL THIRD OF THE FEMUR. THE SURGEON NOTED THAT THE PT HAD VERY OSTEOPOROTIC BONE. THE SURGEON NOTICED THE BREAK DURING SURGERY AND REMOVED THE NAIL. HE REPLACED IT WITH AN AOS SHORT TROCHANTERIC NAIL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AOS TROCHANTERIC NAIL | INTERMEDULLARY ROD | HSB | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. | 1058-305 | 10043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 94 YR | Required Intervention |