MAUDE Adverse Event Report: SONOMA ORTHOPEDIC PRODUCTS, INC. SONOMA CRX; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/23/2016

Event Type  Injury  

Manufacturer Narrative

Information needed to investigate this event was not available at the time of this report.Device not returned for evaluation.

Event Description

Sonoma received a x-ray image showing a broken crx implant.Follow-up with distributor representative revealed that a removal and revision surgery was scheduled.

• Brand Name: SONOMA CRX
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SONOMA ORTHOPEDIC PRODUCTS, INC.; 1388 busch parkway; buffalo grove IL 60089
• Manufacturer (Section G): SONOMA ORTHOPEDIC PRODUCTS, INC.; 1388 busch parkway; buffalo grove IL 60089
• Manufacturer Contact: jeremy moore ; 1388 busch parkway; buffalo grove, IL 60089 ; 8478074378
• MDR Report Key: 6202167
• MDR Text Key: 63206445
• Report Number: 3007038372-2016-00006
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K092110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention