FDA Adverse Event
Injury
Summary report: N
M-ALGNT TUBE W/O RING
MDR report key: 241999
·
Received September 23, 1999
Report
- Report Number
- 1825034-1999-00085
- Event Type
- Injury
- Date Received
- September 23, 1999
- Date of Event
- August 23, 1999
- Report Date
- September 21, 1999
- Manufacturer
- BIOMET, INC.
- Product Code
- FZX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING PREPARATION FOR INTERNAL FIXATION OF FRACTURED FEMUR ON 08/23/1999, THE TIP SECTION OF THE MEDULLARY ALIGNMENT TUBE SEPARATED. SURGEON ELECTED NOT TO REMOVE TIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M-ALGNT TUBE W/O RING | GUIDE, ORTHOPEDIC, INSTRUM. | FZX | BIOMET, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |