TRUMATCH SD980.001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-14 for TRUMATCH SD980.001 manufactured by Materialise Nv.

Event Text Entries

[179420971] 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.
Patient Sequence No: 1, Text Type: N, H10


[179420972] Revision surgery needed because screws backing out of the plate.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003998208-2020-00001
MDR Report Key9710934
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-02-14
Date of Report2020-01-17
Date of Event2019-11-27
Date Mfgr Received2020-01-17
Device Manufacturer Date2019-11-19
Date Added to Maude2020-02-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. JENNY JONES
Manufacturer StreetTECHNOLOGIELAAN 15
Manufacturer CityLEUVEN, VLAAMS-BRABANT 3001
Manufacturer CountryBE
Manufacturer Postal3001
Manufacturer G1MATERIALISE NV
Manufacturer StreetTECHNOLOGIELAAN 15
Manufacturer CityLEUVEN, 3001
Manufacturer CountryBE
Manufacturer Postal Code3001
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRUMATCH
Generic NameTRUMATCH ORTHOGNATHIC - FULL BIMAXILLARY SURGICAL KIT
Product CodeJEY
Date Received2020-02-14
Model NumberSD980.001
Catalog NumberSD980.001
Lot NumberME19ECIFIH
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMATERIALISE NV
Manufacturer AddressTECHNOLOGIELAAN 15 LEUVEN, VLAAMS-BRABANT 3001 BE 3001


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-14

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