MAUDE Adverse Event Report: KIRSHNER WIRE, K-WIRE; PIN FIXATION, SMOOTH

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 04/01/1954

Event Type  Injury  

Event Description

No medical records available.Hospital closed for years.Upon a rear end accident i have been through pain suffering.Many mds unable to diagnose problem, not visible.After plastics ent and research found, ct confirmed, facial and/or sinus replacement with k wire, probably at birth.I am now almost (b)(6) and this has been a nightmare.I spent my entire working life as a (b)(6).Please help me locate any info the fda might have.(b)(6).Thank you in advance.K wire used for ent surgery in 1954.

• Brand Name: KIRSHNER WIRE, K-WIRE
• Type of Device: PIN FIXATION, SMOOTH
• MDR Report Key: 7637964
• MDR Text Key: 112498130
• Report Number: MW5078069
• Device Sequence Number: 1
• Product Code: HTY
• 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: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly; Required Intervention; Disability
• Patient Age: 64 YR