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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; SPLINT AND PLANNING KIT, ORTHOGNATHIC KIT, TWO SPLINTS
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MATERIALISE NV TRUMATCH; SPLINT AND PLANNING KIT, ORTHOGNATHIC KIT, TWO SPLINTS Back to Search Results
Model Number SD900.008
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Physical Asymmetry (4573)
Date of Event 04/19/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The left condyle being out of the fossa influenced the planning and outcome.Return of splints not required as there were no issues with the fit and the root cause is already known.Initial attempt to upload file was made on (b)(6) 2021 but failed.Helpdesk was contacted (ticket (b)(4)).
 
Event or Problem Description
Maxilla and mandible middline not as planned after surgery.
 
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Brand Name
TRUMATCH
Common Device Name
SPLINT AND PLANNING KIT, ORTHOGNATHIC KIT, TWO SPLINTS
Manufacturer (Section D)
MATERIALISE NV
technologielaan 15
leuven, vlaams-brabant 3001
BE  3001
MDR Report Key12014699
Report Number3003998208-2021-00007
Device Sequence Number14252448
Product Code HWT
UDI-Device Identifier05420060350573
UDI-Public05420060350573
Combination Product (Y/N)N
Initial Reporter CountryAS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/03/2021
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 NumberSD900.008
Device Catalogue NumberSD900.008
Device Lot NumberME21XOJOTE
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/03/2021
Initial Report FDA Received Date06/17/2021
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;
Patient Age23 YR
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