FDA Adverse Event
Injury
Summary report: N
WAVEON CRX
MDR report key: 1802545
·
Received August 6, 2010
Report
- Report Number
- 3007038372-2010-00006
- Event Type
- Injury
- Date Received
- August 6, 2010
- Date of Event
- June 13, 2010
- Report Date
- August 5, 2010
- Manufacturer
- SONOMA ORTHOPEDIC PRODUCTS, INC.
- Product Code
- HSB
- PMA / PMN Number
- K081832
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AT 6 WEEKS POST-OP, PT DIAGNOSED AS PROLONGED NON-UNION AND X-RAY REVEALED DAMAGED IMPLANT. PT REVISED WITH REPLACEMENT SONOMA ORTHOPEDIC PRODUCTS IMPLANT AND DOCTOR COMMENTED THAT PT WOULD ALSO BE INSTRUCTED TO LIMIT MOBILITY (NOT SO INSTRUCTED AFTER ORIGINAL SURGERY PER PHYSICIAN).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WAVEON CRX | CLAVICLE INTRAMEDULLARY BONE FIXATION | HSB | SONOMA ORTHOPEDIC PRODUCTS, INC. | CRX-GWG | CU210709-03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |