FDA Adverse Event
Injury
Summary report: N
WAVEON CRX
MDR report key: 1815421
·
Received August 20, 2010
Report
- Report Number
- 3007038372-2010-00008
- Event Type
- Injury
- Date Received
- August 20, 2010
- Date of Event
- July 21, 2010
- Report Date
- August 20, 2010
- Manufacturer
- SONOMA ORTHOPEDIC PRODUCTS INC.
- Product Code
- HSB
- PMA / PMN Number
- K081832
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IMPLANT DATE: (B)(6) 2010. TWO WEEKS POST-OP, PT PARTICIPATED IN A FOOTBALL GAME AND BENT IMPLANT AS A RESULT OF BEING TACKLED (PER PT INPUT). DEVICE EXPLANTED ON (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WAVEON CRX | CLAVICLE INTRAMEDULLARY BONE FIXATION | HSB | SONOMA ORTHOPEDIC PRODUCTS INC. | CRX-WG2-40100 | CU060410-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |