MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH CMF; PLATE, BONE

Model Number SD980.020

Device Problems Fracture (1260); Physical Property Issue (3008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/25/2017

Event Type  Injury  

Manufacturer Narrative

A review of internal documentation is in progress.An updated report will be filed when the investigation has been completed.

Event Description

A patient specific plate was used to perform a mandible reconstruction.It was reported that the 3d printed plate for this case broke after 6 months.By then the reconstruction had already nicely healed, so the surgeon didn't consider it as a big issue and just took it out.

Manufacturer Narrative

A review of the internal documentation did not show an anomaly or deviation.The device design met the surgeon's expectations and met specifications.A cause for this specific clinical event cannot be ascertained from the information provided.Should additional information become available and/or the device be returned for evaluation and an investigation result be available that changes this assessment, an amended medical device report will be filed.

Event Description

A patient specific plate was used to perform a mandible reconstruction.It was reported that the 3d printed plate for this case broke after 6 months.By then the reconstruction had already nicely healed so the surgeon didn't consider it as a big issue and just took it out.

• Brand Name: TRUMATCH CMF
• Type of Device: PLATE, BONE
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, 3001 ; BE 3001
• Manufacturer (Section G): MATERIALISE NV; technologielaan 15; leuven, 3001 ; BE 3001
• Manufacturer Contact: jenny jones ; 44650 helm court; plymouth, MI 48170 ; 7342597017
• MDR Report Key: 7524881
• MDR Text Key: 108608907
• Report Number: 3003998208-2018-00003
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060380204
• UDI-Public: 05420060380204
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• 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: ME17IZUVAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2017
• 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: 37 YR