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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 Failure of Implant (1924)
Date of Event 11/27/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
A review of the internal documentation did not show an anomaly or deviation.A cause for this specific clinical event cannot be ascertained from the information provided.Should additional information become available and/or the device be returned for evaluation and an investigation result be available that changes this assessment, an amended medical device report will be filed.
 
Event or Problem Description
Revision surgery needed because screws backing out of the plate.
 
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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 Key9710934
Report Number3003998208-2020-00001
Device Sequence Number2482794
Product Code JEY
UDI-Device Identifier05420060380013
UDI-Public05420060380013
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K170272
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/17/2020
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 NumberME19ECIFIH
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/17/2020
Initial Report FDA Received Date02/14/2020
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 Age44 YR
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