MAUDE Adverse Event Report: KLS MARTIN GMBH TITANIUM MESH PLATES; PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE

Model Number 25-302-13-09

Device Problem Insufficient Information (3190)

Patient Problems Fatigue (1849); Fever (1858); Headache (1880); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Blurred Vision (2137); Burning Sensation (2146); Shaking/Tremors (2515); Ambulation Difficulties (2544); Confusion/ Disorientation (2553); Weight Changes (2607)

Event Date 02/09/2015

Event Type  Injury  

Event Description

Patient reports having tremors and ambulation difficulties post cranioplasty.After 10-15 minutes of entering any building her symptoms begin.Symptoms include burning sensation on her tongue, different states of consciousness, double vision, eye pain, loss of balance, weight loss, memory loss, confusion, headaches, metal taste in mouth, chronic fatigue, nausea, no appetite, a well as constant low grade fevers (99-100).Patient reports she has no motivation to do anything and can no longer complete her day-to-day tasks.

• Brand Name: TITANIUM MESH PLATES
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
• Manufacturer (Section D): KLS MARTIN GMBH
• MDR Report Key: 7373188
• MDR Text Key: 103671434
• Report Number: MW5076147
• Device Sequence Number: 1
• Product Code: GXN
• 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: 03/26/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 25-302-13-09
• Device Catalogue Number: 82719
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 56