MAUDE Adverse Event Report: MATERIALISE NV TRUMATCH; TRUMATCH ORTHOGNATHICS - BASIC MANDIBULAR SURGICAL KIT

Model Number SD980.011

Device Problem Malposition of Device (2616)

Patient Problem Physical Asymmetry (4573)

Event Date 12/16/2021

Event Type  Injury  

Event Description

Patient has assymetry in the chin area.

Manufacturer Narrative

Devices met specifications.Post-op analysis showed guide and plate were misplaced by the surgeon.Device discarded by surgeon.

• Brand Name: TRUMATCH
• Type of Device: TRUMATCH ORTHOGNATHICS - BASIC MANDIBULAR SURGICAL KIT
• 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: 13597532
• MDR Text Key: 286122053
• Report Number: 3003998208-2022-00003
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 05420060380112
• UDI-Public: 05420060380112
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 02/07/2022

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
• Device Operator: Health Professional
• Device Model Number: SD980.011
• Device Catalogue Number: SD980.011
• Device Lot Number: ME21IRODAZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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 Sex: Male