FDA Adverse Event
Malfunction
Summary report: N
TSRH 3D 6.5 X 50 MM SCREW, TI
MDR report key: 915879
·
Received August 19, 2004
Report
- Report Number
- 1030489-2004-00091
- Event Type
- Malfunction
- Date Received
- August 19, 2004
- Date of Event
- July 20, 2004
- Report Date
- July 20, 2004
- Manufacturer
- MEDTRONIC SOFAMOR DANEKMANUFACTURING
- Product Code
- KWG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TSRH 3D 6.5 X 50 MM SCREW, TI | BONE SCREW | KWG | MEDTRONIC SOFAMOR DANEKMANUFACTURING | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR |