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

Model Number	SD980.001
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Physical Asymmetry (4573); Insufficient Information (4580)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Final occlusion outcome not as planned.Revision required.
Additional Manufacturer Narrative
Investigation ongoing.Device location unknown.
Additional Manufacturer Narrative
Devices met specifications.Surgeon placed the guides too posterior.H3: devices were requested back but only plates were received.The guides were not returned.

• 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
• Manufacturer (Section G): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• Manufacturer Contact: jenny jones ; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 12702820
• Report Number: 3003998208-2021-00014
• Device Sequence Number: 11915667
• Product Code: JEY
• UDI-Device Identifier: 05420060380013
• UDI-Public: 05420060380013
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 10/01/2021

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 Number: SD980.001
• Device Catalogue Number: SD980.001
• Device Lot Number: MU21RIVAJA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male