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

Model Number	SD980.011
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Physical Asymmetry (4573)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient has assymetry in the chin area.
Additional Manufacturer Narrative
Devices met specifications.Post-op analysis showed guide and plate were misplaced by the surgeon.Device discarded by surgeon.

• Brand Name: TRUMATCH
• Common Device Name: 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
• Report Number: 3003998208-2022-00003
• Device Sequence Number: 1969406
• Product Code: JEY
• UDI-Device Identifier: 05420060380112
• UDI-Public: 05420060380112
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male