MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; TRUMATCH ORTHOGNATHICS - FULL BIMAXILLARY SURGICAL KIT

Model Number	SD980.001
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is ongoing.Device not yet explanted.
Event or Problem Description
After the surgery, it was found that the occlusion was off and that this resulted in the patient having an over bite.Surgeon is discussing with patient whether to have a revision surgery or not.
Additional Manufacturer Narrative
Investigation concluded that the bad occlusion was caused by a user error by the surgeon, who did not follow the instructions.The surgeon did not place a graft which was planned to be placed.This caused the maxilla to move when forces were applied.Splint and guides were discarded by surgeon, plates still in patient only fields that have additional information have been completed, all other fields are kept empty as they were reported in the initial report and still correct.
Event or Problem Description
After the surgery, it was found that the occlusion was off and that this resulted in the patient having an over bite.Surgeon did coronoidectomy in week 45 and will do revision surgery when patient returns to town in 6 months.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH ORTHOGNATHICS - FULL BIMAXILLARY SURGICAL KIT
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 10788165
• Report Number: 3003998208-2020-00012
• Device Sequence Number: 14180197
• Product Code: JEY
• UDI-Device Identifier: 05420060380013
• UDI-Public: 05420060380013
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

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 Number: SD980.001
• Device Catalogue Number: SD980.001
• Device Lot Number: MU20POZFOQ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR