FDA Adverse Event
Other
Summary report: N
SMALL FRAGMENT 4X2 HOLE RECTANGLE PLATE
MDR report key: 594646
·
Received April 22, 2005
Report
- Report Number
- 1032347-2005-00005
- Event Type
- Other
- Date Received
- April 22, 2005
- Report Date
- February 14, 2005
- Manufacturer
- WALTER LORENZ SURGICAL, INC.
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
RECEIVED NOTIFICATION PLATE BROKE SEVERAL DAYS AFTER IMPLANTATION. SURGICAL SITE - CARPAL BONE, SURGICAL PROCEDURE - OSTENOSYNTHESIS OF THE CARPAL BONE FOR THE ARTHRODESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SMALL FRAGMENT 4X2 HOLE RECTANGLE PLATE | PLATE | HRS | WALTER LORENZ SURGICAL, INC. | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization| O |