FDA Adverse Event
Injury
Summary report: N
WAVEON CRX GWG
MDR report key: 1624869
·
Received March 5, 2010
Report
- Report Number
- 3007038372-2009-00010
- Event Type
- Injury
- Date Received
- March 5, 2010
- Date of Event
- February 16, 2010
- Report Date
- March 5, 2010
- Manufacturer
- SONOMA ORTHOPEDIC PRODUCTS INC.
- Product Code
- HSB
- PMA / PMN Number
- K081832
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
RECEIVED A REPORT THAT THE PT HAD A NON UNION. F/U INDICATES PT FELL, BROKE THE CLAVICLE IMPLANT, AND RE-BROKE THE CLAVICLE. PT WAS REVISED AND DEVICE IS NOT BEING RETURNED. FURTHER DETAILS ARE NOT KNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WAVEON CRX GWG | CLAVICLE INTRAMEDULLARY BONE FIXATION | HSB | SONOMA ORTHOPEDIC PRODUCTS INC. | CU230709-25 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |