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

Model Number SD980.014

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Erosion (1750); Insufficient Information (4580)

Event Date 08/13/2018

Event Type  Injury  

Manufacturer Narrative

Investigation ongoing.Device discarded.

Event Description

Surgeon reported an issue with the maxilla plate post-operatively and the need for removal of the plate.

Manufacturer Narrative

The device met specifications but the patient condition let to the exposure of the plate.The large maxillary advancement needed for this patient in combination with the weak soft tissues led to the exposure of the plate.D6b: the exposure occurred 6 to 8 weeks after the surgery.6 weeks post-op would be in (b)(6) 2018.

• Brand Name: TRUMATCH
• Type of Device: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MIDFACE
• 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: 12390505
• MDR Text Key: 268894676
• Report Number: 3003998208-2021-00011
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060380143
• UDI-Public: 05420060380143
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SD980.014
• Device Catalogue Number: SD980.014
• Device Lot Number: MC18UTOPOX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2018
• 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): Other
• Patient Age: 20 YR
• Patient Sex: Female