FDA Adverse Event
Injury
Summary report: N
EIGHT-PLATE GUIDED GROWTH SYSTEM SCREW, 24MM
MDR report key: 1348915
·
Received March 20, 2009
Report
- Report Number
- 2183449-2009-00002
- Event Type
- Injury
- Date Received
- March 20, 2009
- Report Date
- March 18, 2009
- Manufacturer
- ORTHOFIX INC.
- Product Code
- HWC
- PMA / PMN Number
- K031493
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PROVIDED INFORMATION STATES THAT THE SCREW BROKE ALONG THE THREAD DURING TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EIGHT-PLATE GUIDED GROWTH SYSTEM SCREW, 24MM | BONE SCREW, 24MM | HWC | ORTHOFIX INC. | GP224 | 126G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |