FDA Adverse Event
Injury
Summary report: N
PRESSURE SENTINEL INTRAMEDULLARY REAMING SYSTEM FLEXIBLE REA
MDR report key: 448206
·
Received March 13, 2003
Report
- Report Number
- 1822565-2003-00030
- Event Type
- Injury
- Date Received
- March 13, 2003
- Report Date
- February 10, 2003
- Manufacturer
- ZIMMER, INC.
- Product Code
- HTO
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE SURGEON USED THE PRESSURE SENTINEL REAMER SYSTEM ON A PATIENT WITH A TIBIAL FRACTURE AND WHILE IN USE EXPERIENCED A POSTERIOR WALL BLOW OUT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRESSURE SENTINEL INTRAMEDULLARY REAMING SYSTEM FLEXIBLE REA | FLEXIBLE REAMER | HTO | ZIMMER, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R |