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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 Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 02/10/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Guides were designed and manufactured according to specifications but were not positioned according to the plan during the surgery.This led to an incorrect location of the osteotomies and mandible plates, which is the most likely root cause for the condyles coming out of the fossa.
 
Event or Problem Description
Post-op images showed that condyles were out of the fossa.Therefore revision surgery will be needed.
 
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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 Key9841234
Report Number3003998208-2020-00003
Device Sequence Number16865545
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
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/18/2020
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 NumberMU20PUJBOL
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/18/2020
Initial Report FDA Received Date03/17/2020
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 Age37 YR
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