Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; TITANIUM 3D PRINTED PLATE FOR MIDFACE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MATERIALISE NV TRUMATCH; TITANIUM 3D PRINTED PLATE FOR MIDFACE Back to Search Results
Model Number SD980.014
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 08/19/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
During the investigation, several steps that could contribute to the infection complaint were investigated.No issues were found.Everything was planned and designed according to the work instructions.Device was not available for return.
 
Event or Problem Description
Revision surgery of left maxilla because of an infection.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRUMATCH
Common Device Name
TITANIUM 3D PRINTED PLATE FOR MIDFACE
Manufacturer (Section D)
MATERIALISE NV
technologielaan 15
leuven, vlaams-brabant 3001
BE  3001
MDR Report Key11670082
Report Number3003998208-2021-00005
Device Sequence Number3050027
Product Code JEY
UDI-Device Identifier05420060380143
UDI-Public05420060380143
Combination Product (Y/N)N
Initial Reporter CountryDA
PMA/510(K) Number
K170272
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model NumberSD980.014
Device Catalogue NumberSD980.014
Device Lot NumberME20GENAGA
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/17/2021
Initial Report FDA Received Date04/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-