FDA Adverse Event
Summary report: N
MYOMA SCREW 5MM, 32CM
MDR report key: 542036
·
Received September 3, 2004
Report
- Report Number
- 2430952-2004-00026
- Date Received
- September 3, 2004
- Report Date
- September 3, 2004
- Manufacturer
- TROKAMED HENGSTLER GMBH
- Product Code
- KOG
- Report Source
- Distributor report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE INSTRUMENT WAS BEING USED FOR THE FIRST TIME. THE SHAFT IS BENT AND A BREAK OCCURRED CLOSED TO THE HANDLE. SAMPLE TO BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MYOMA SCREW 5MM, 32CM | ENDOSCOPIC INSTRUMENTS | KOG | TROKAMED HENGSTLER GMBH | * | 16886 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |