MAUDE Adverse Event Report: ORTHOFIX INC. ORTHOFIX FIXATOR; "PIN, FIXATION, THREADED"

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091)

Event Date 11/05/2018

Event Type  malfunction  

Event Description

Reporter states that on (b)(6) 2018 he had an orthofix fixator on his right foot.Later that week he noticed pain and swelling on his right foot.He went to the er and was given antibiotics.On the following monday, (b)(6) 2018 pain and swelling were lessened but still persisted.

• Brand Name: ORTHOFIX FIXATOR
• Type of Device: "PIN, FIXATION, THREADED"
• Manufacturer (Section D): ORTHOFIX INC.
• MDR Report Key: 8070257
• MDR Text Key: 127342807
• Report Number: MW5081214
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 100