MAUDE Adverse Event Report: EXTERNAL FIXATOR WITH SCREWS; SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Date 10/11/2023

Event Type  Injury  

Event Description

I was at work sitting at my desk when i felt something pop in my hand followed by severe pain.I had surgery and have 4 screws/pins with an apparatus on the outside to hold the screws.I did fall or use my hand.Hand x-ray shows 2 screws/pins broken in half."princess".

• Brand Name: EXTERNAL FIXATOR WITH SCREWS
• Type of Device: SYSTEM, EXTERNAL FIXATOR (WITH METALLIC INVASIVE COMPONENTS)
• MDR Report Key: 18065040
• MDR Text Key: 327526985
• Report Number: MW5147706
• Device Sequence Number: 1
• Product Code: NDK
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2023
• Patient Sequence Number: 1
• Treatment: CRESTOR 40MG; EZETIMIBE 10MG
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Hispanic
• Patient Race: White