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

Model Number SD980.020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteomyelitis (4533)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

Investigation ongoing.Device still in patient.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 301547814
• Report Number: 3003998208-2022-00023
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060380204
• UDI-Public: 05420060380204
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male