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

Model Number SD980.016

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is ongoing, follow-up report will be provided when more information is available.

Event Description

Surgeon informed depuy synthes that there was one patient who had a broken mandible plate on the right side, which he had to revise.

Manufacturer Narrative

No issues found in design or manufacturing.Plate broke prematurely.H3: device requested to be returned, but no reply received.Initial attempt to upload file was made on (b)(6) 2021 but failed.Helpdesk was contacted (ticket 270999 and 271678).

Event Description

Surgeon informed depuy synthes that there was one patient who had a broken mandible plate on the right side, which he had to revise.

• Brand Name: TRUMATCH
• Type of Device: TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI
• Manufacturer (Section D): MATERIALISE NV; technologielaan 15; leuven, vlaams-brabant 3001 ; BE 3001
• MDR Report Key: 11055421
• MDR Text Key: 223164313
• Report Number: 3003998208-2020-00013
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060380167
• UDI-Public: 05420060380167
• Combination Product (y/n): N
• PMA/PMN Number: K170272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD980.016
• Device Catalogue Number: SD980.016
• Device Lot Number: ME19SECJAX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR