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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; TRUMATCH ORTHOGNATHIC - FULL BIMAXILLARY SURGICAL KIT
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MATERIALISE NV TRUMATCH; TRUMATCH ORTHOGNATHIC - FULL BIMAXILLARY SURGICAL KIT Back to Search Results
Model Number SD980.001
Medical Device Problem Code Malposition of Device (2616)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 06/24/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Based on initial findings, the left mandible guide and therefore also plate seem to have been misplaced.Further investigation is ongoing.Maxilla and genio plate still in patient, only mandible plates were removed and replaced.
 
Event or Problem Description
Revision surgery needed as mandible did not advance as planned and caused the occlusion to be off.
 
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Brand Name
TRUMATCH
Common Device Name
TRUMATCH ORTHOGNATHIC - FULL BIMAXILLARY SURGICAL KIT
Manufacturer (Section D)
MATERIALISE NV
technologielaan 15
leuven, vlaams brabant 3001
BE  3001
MDR Report Key10371927
Report Number3003998208-2020-00009
Device Sequence Number14314438
Product Code JEY
UDI-Device Identifier05420060380013
UDI-Public05420060380013
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K170272
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/07/2020
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 NumberSD980.001
Device Catalogue NumberSD980.001
Device Lot NumberMU20ZOXCUQ
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/07/2020
Initial Report FDA Received Date08/06/2020
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;
Patient Age62 YR
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