FDA Adverse Event
Injury
Summary report: N
SULZER SPINE-TECH BONE HARVESTER
MDR report key: 208584
·
Received February 2, 1999
Report
- Report Number
- 2184052-1999-00001
- Event Type
- Injury
- Date Received
- February 2, 1999
- Date of Event
- November 11, 1998
- Report Date
- February 1, 1999
- Manufacturer
- SULZER SPINE-TECH
- Product Code
- HWE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE CUTTING HEAD OF THE POWER BONE HARVESTER BROKE OFF OF THE INSTRUMENT DURING USE AND COULD NOT BE RETRIEVED FROM THE ILIAC CREST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SULZER SPINE-TECH BONE HARVESTER | AUTOGENOUS BONE HARVESTER | HWE | SULZER SPINE-TECH | NA | P980169 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Other |