FDA Adverse Event
Injury
Summary report: N
IMPACTOR / LXH
MDR report key: 1354293
·
Received April 1, 2009
Report
- Report Number
- 1020279-2009-00537
- Event Type
- Injury
- Date Received
- April 1, 2009
- Date of Event
- March 12, 2009
- Report Date
- March 31, 2009
- Manufacturer
- BROOKS MANUFACTURING SITE
- Product Code
- LXH
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPACTOR BROKE OFF DURING THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IMPACTOR / LXH | LXH | BROOKS MANUFACTURING SITE | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other |