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

Model Number	SD980.020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteomyelitis (4533)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation ongoing.Device still in patient.
Event or Problem Description
Patient presented with persistent swelling and osteomyelitis/infection.Surgeons reviewed ct scans and see some bone degradation and loose screws.Surgeons suspect that the patient did not heal well from the original surgery and the infection came first and caused the loose screws (but there is no way to tell).Patient also has type ii diabetes which they think was a contributing factor.Existing plate will be removed, fibula and ramus segment slightly repositioned and then new milled plate put on.
Additional Manufacturer Narrative
"investigation concluded that the device met specifications and did not malfuction.It was in surgeons' opinion that the patient did not heal well leading to the infection which then caused screws loosening.An other possible contributing factor was that the patient had type ii diabetes.".
Event or Problem Description
"patient presented with persistent swelling and osteomyelitis/infection.Surgeons reviewed ct scans and see some bone degradation and loose screws.Surgeons suspect that the patient did not heal well from the original surgery and the infection came first and caused the loose screws (but there is no way to tell).Patient also has type ii diabetes which they think was a contributing factor.Existing plate will be removed, fibula and ramus segment slightly repositioned and then new milled plate put on.".

• Brand Name: TRUMATCH
• Common Device Name: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MEDIUM
• 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: 15585853
• Report Number: 3003998208-2022-00023
• Device Sequence Number: 2809648
• Product Code: JEY
• UDI-Device Identifier: 05420060380204
• UDI-Public: 05420060380204
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2022

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: SD980.020
• Device Catalogue Number: SD980.020
• Device Lot Number: MU22SORGUH
• 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: 10/03/2022
• Supplement Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male