MAUDE Adverse Event Report: SYNTHES SYNTHES TITANIUM MESH; NONE

Device Problems Device Operates Differently Than Expected (2913); Extrusion (2934)

Patient Problems Erosion (1750); Pain (1994); Tissue Damage (2104)

Event Date 07/10/2007

Event Type  Injury  

Event Description

The patient's mother reported that the pt was born with active shingles.In 2003, she had surgery for chiari malformation.In 2004, she had another surgery for berry aneurysm.On (b)(6) 2015, pt had synthes titanium plate implanted in her scalp at (b)(6) hospital, (b)(6).The pt developed pain in her head and became worse over the years.The surgeon told the pt the pain is because of the bone growth and it will go away.Pt cannot bear when the water is touching her scalp.She can feel the screws on her scalp.Pt had open skin on her scalp and the silver plate is exposed.The titanium plate is for skull reconstruction but it did not help the bone growth as it is supposed to.Pt implant surgeon moved to australia and pt follow up with another surgeon for the pain and exposed implant.Pt is currently taking less than 7 medications.

• Brand Name: SYNTHES TITANIUM MESH
• Type of Device: NONE
• Manufacturer (Section D): SYNTHES
• MDR Report Key: 4628007
• MDR Text Key: 5571263
• Report Number: MW5041591
• Device Sequence Number: 1
• Product Code: GWO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Weight: 64