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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI
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MATERIALISE NV TRUMATCH; MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI Back to Search Results
Model Number SD980.016
Device Problems Device Appears to Trigger Rejection (1524); Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 12/02/2019
Event Type  Injury  
Manufacturer Narrative
Device was designed and manufactured according to specifications.There was no change in the cleaning or sterilisation process.Additional investigation is still ongoing.
 
Event Description
The patient underwent a bi-sagittal split osteotomy of the mandible.Post-operative an infection was reported.The plate(s) will be removed (date not yet decided).
 
Manufacturer Narrative
After concluding the investigation, a most likely root cause was identified.A high position of the plate on the mandible could be related to an increased risk of infection.
 
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Brand Name
TRUMATCH
Type of Device
MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI
Manufacturer (Section D)
MATERIALISE NV
technologielaan 15
leuven, 3001
BE  3001
MDR Report Key9725662
MDR Text Key189913314
Report Number3003998208-2020-00002
Device Sequence Number1
Product Code JEY
UDI-Device Identifier05420060380167
UDI-Public05420060380167
Combination Product (y/n)N
PMA/PMN Number
K170272
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberSD980.016
Device Catalogue NumberSD980.016
Device Lot NumberMU19LALSUS
Was Device Available for Evaluation? No
Date Manufacturer Received04/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age18 YR
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