FDA Adverse Event
Injury
Summary report: N
4.0MM TI CORTEX EXPANSIONHEAD SCREW
MDR report key: 414197
·
Received September 4, 2002
Report
- Report Number
- 2520274-2002-00017
- Event Type
- Injury
- Date Received
- September 4, 2002
- Date of Event
- July 31, 2002
- Report Date
- August 8, 2002
- Manufacturer
- SYNTHES (USA)
- Product Code
- KWQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A LOCKING SCREW BACKED OUT OF AN IMPLANTED CSLP AND WAS REMOVED APPROXIMATELY 07/2002.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.0MM TI CORTEX EXPANSIONHEAD SCREW | EXPANSIONHEAD SCREWS | KWQ | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention | CSLP, SCREWS. |