MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI

Model Number	SD980.016
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Difficulty Chewing (4522)
Date of Event	11/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device met specifications.Patient's bone did not heal in a timely manner as it is still not healed after 8 months.Replacement surgery planned for (b)(6) 2022.X-ray images of the broken plate provide sufficient information.
Event or Problem Description
Left bsso plate broke after approximately 8 months and will be replaced with new bsso plate.
Additional Manufacturer Narrative
Both bsso plates met specifications.Patient's bone did not heal in a timely manner as it is still not healed after 8 - 10 months.H3: x-ray images and pictures of the broken plates provide sufficient information.
Event or Problem Description
Left bsso plate broke after approximately 8 months and will be replaced with new bsso plate.Additionally, the right bsso plate broke after approximately 8 -10 months and will be replaced with new bsso plate.Revision surgery scheduled for (b)(6) 2022.

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI
• 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: 15238847
• Report Number: 3003998208-2022-00017
• Device Sequence Number: 4899764
• Product Code: JEY
• UDI-Device Identifier: 05420060380167
• UDI-Public: 05420060380167
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 08/01/2022

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: SD980.016
• Device Catalogue Number: SD980.016
• Device Lot Number: ME21IMUHOD
• 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: 08/01/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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 Age: 48 YR
• Patient Sex: Male