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; TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED GUIDE FOR MANDIBLE
  • 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; TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED GUIDE FOR MANDIBLE Back to Search Results
Model Number SD980.017
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Nerve Damage (1979); Insufficient Information (4580)
Date of Event 12/11/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Investigation ongoing.
 
Event or Problem Description
The mandible saggital split cut has damaged the nerve.
 
Additional Manufacturer Narrative
Device was designed and manufactured according to specification.Root cause could not be established.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRUMATCH
Common Device Name
TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED GUIDE FOR MANDIBLE
Manufacturer (Section D)
MATERIALISE NV
technologielaan 15
leuven, vlaams-brabant 3001
BE  3001
MDR Report Key11160597
Report Number3003998208-2021-00001
Device Sequence Number3719413
Product Code JEY
UDI-Device Identifier05420060380174
UDI-Public05420060380174
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K170272
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/14/2020
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 NumberSD980.017
Device Catalogue NumberSD980.017
Device Lot NumberME20CEQQOL
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/14/2020
Supplement Date Received by Manufacturer02/02/2021
Initial Report FDA Received Date01/13/2021
Supplement Report FDA Received Date02/24/2021
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;
-
-