FDA Adverse Event
Injury
Summary report: N
SONOMA CRX
MDR report key: 3676760
·
Received February 25, 2014
Report
- Report Number
- 3007038372-2014-00001
- Event Type
- Injury
- Date Received
- February 25, 2014
- Date of Event
- December 26, 2013
- Report Date
- February 21, 2014
- Manufacturer
- SONOMA ORTHOPEDIC PRODUCTS INC.
- Product Code
- HSB
- PMA / PMN Number
- K092110
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PTS XRAY'S CONFIRM THAT THE DEVICE WAS NOT PLACED ACCORDING TO THE IFU AND SURGICAL TECHNIQUE GUIDE. SONOMA'S SURGICAL TECHNIQUE GUIDE CLEARLY SPECIFIES THE MINIMUM IMPLANT DEPTH TO ENSURE ADEQUATE FRACTURE SUPPORT. THE SURGEON DID NOT FOLLOW THE INSTRUCTIONS FOR USE AND FAILED TO PLACE THE IMPLANT TO THE SPECIFIED DEPTH, LEADING TO IMPLANT FAILURE.
Description of Event or Problem · 1
A SONOMA CRX-CWG WAS REMOVED FROM A PT WHO HAD BEEN PREVIOUSLY IMPLANTED. THE IMPLANT WAS REMOVED ON (B)(6) 2013, BECAUSE THE IMPLANT WAS BROKEN. THE X-RAY, WHICH WAS REC'D, SHOWS THE DEVICE WAS NOT IMPLANTED DEEP ENOUGH. THE DEVICE WAS NOT RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116135 | SONOMA CRX | CRX | HSB | SONOMA ORTHOPEDIC PRODUCTS INC. | CRX-WG2-40100 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |