MAUDE Adverse Event Report: PIN

Device Problem Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Cyst(s) (1800); Hypersensitivity/Allergic reaction (1907); Pain (1994); Staphylococcus Aureus (2058)

Event Date 01/01/2008

Event Type  Injury  

Event Description

In 2008, pt was in a mva which required surgery on his back, hip, shoulder, leg, arm and pelvis.During the surgery, the surgeon implanted pins, plates and wires for multiple fractures the patient sustained.From 2008-2011, pt had multiple hospital visits due to the implants.Pt c/o-cysts on spine, pain allergic reaction to the implants and (b)(6).In 2011, pt had all implants removed.

• Brand Name: PIN
• Type of Device: PIN
• MDR Report Key: 3983475
• MDR Text Key: 21492616
• Report Number: MW5037611
• Device Sequence Number: 1
• Product Code: HTY
• 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: 08/05/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR