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U.S. Department of Health and Human Services

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

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KLS MARTIN GMBH TITANIUM MESH PLATES PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE Back to Search Results
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.
 
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Brand NameTITANIUM MESH PLATES
Type of DevicePLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
Manufacturer (Section D)
KLS MARTIN GMBH
MDR Report Key7373188
MDR Text Key103671434
Report NumberMW5076147
Device Sequence Number1
Product Code GXN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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  
0 Patients were Involved in the Event:
Date FDA Received03/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number25-302-13-09
Device Catalogue Number82719
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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