TruMatch SD980.014Recalls & reported problems
Materialise NV · TRUMATCH Midface/Mandible - Titanium 3D Printed Plate for Midface · Class 2 · Implant
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05420060380143), received between Apr 15, 2021 and Jan 8, 2026 — classified as 20 injuries.
The most frequently reported specific device problem is “Fracture” (6 reports).
2 other recalls cover devices cleared under the same FDA submission (K170272); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
- Fracture6
- Break3
- Positioning Failure2
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
- Patient-Device Incompatibility1
Patient problems
- Difficulty Chewing6
- Implant Pain4
- Insufficient Information4
- Physical Asymmetry3
- Unspecified Infection3
- Erosion1
- Necrosis1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
InjuryJan 8, 2026Break
IT WAS REPORTED THAT THE MAXILLARY PLATE BROKE POST-OPERATIVELY. THE ADDITIONAL SURGICAL INTERVENTION IS NEEDED TO REMOVE THE PLATE.
Patient problems: Difficulty Chewing
MAUDE report 24004123 ↗InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A DAY AFTER THE SURGERY THE SURGEON HAD DO REVISION SURGERY USING THE SAME PLATE TO CORRECT BAD OCCLUSION (OPEN BITE AND OVERJET).
Patient problems: Physical Asymmetry
MAUDE report 21392749 ↗InjuryJul 12, 2024No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED ABOUT AN INFECTION ON THE RIGHT SIDE AND A SIGNIFICANT RELAPSE ON THE MANDIBLE. THE PATIENT REQUIRED ADDITIONAL SURGICAL INTERVENTION TO REMOVE THE PLATE.
Patient problems: Unspecified Infection
MAUDE report 19730164 ↗InjuryMar 25, 2024Fracture; Fracture
A POST-OPERATIVE X-RAY APPROXIMATELY 7 MONTHS AFTER THE SURGERY DATE SHOWING BROKEN MAXILLARY HARDWARE IN THE PATIENT.
Patient problems: Implant Pain
MAUDE report 18969257 ↗InjuryMar 6, 2024Break; Break
THE PLATE WAS REPORTED BROKEN 6 MONTHS POST-INITIAL IMPLANTATION. THE REVISION SURGERY IS PLANNED TO EXPLANT IT.
Patient problems: Difficulty Chewing
MAUDE report 18844998 ↗InjuryDec 21, 2023Positioning Failure; Positioning Failure
THE SURGEON STATED THAT ACTUAL MOVEMENTS OBTAINED INTRA-OPERATIVELY DIFFERED VASTLY FROM THE MOVEMENTS PLANNED PRE-OPERATIVELY. A REVISION SURGERY WILL BE PERFORMED TO CORRECT THE POSITION OF THE JAWS.
Patient problems: Difficulty Chewing
MAUDE report 18375398 ↗InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SURGEON REMOVED THE TITANIUM IMPLANT FROM THE PATIENT DUE TO MALOCCLUSION AND REPLACED THE IMPLANT WITH STANDARD PLATES AND SCREWS.
Patient problems: Physical Asymmetry
MAUDE report 18284983 ↗InjuryDec 6, 2023Break; Break
PLATE WAS REPORTED BROKEN AND EXPLANTED FOUR YEARS POST INITIAL IMPLANTATION.
Patient problems: Difficulty Chewing
MAUDE report 18273238 ↗InjuryNov 29, 2023Positioning Failure; Positioning Failure
A REVISION SURGERY IS PLANNED TO FIX THE PATIENT'S OCCLUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18226348 ↗InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SURGEON MUST REMOVE OLD LEFORT PLATE TO PLACE NEW LF PLATE TO FURTHER CORRECT THE BITE.
Patient problems: Physical Asymmetry
MAUDE report 17390019 ↗InjuryJun 20, 2023Fracture; Fracture
IT WAS REPORTED THAT A BROKEN TRUMATCH PLATE WAS REMOVED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 17162644 ↗InjuryJul 26, 2022Fracture; Fracture
PATIENT EXPERIENCED DISCOMFORT AND SWELLING AND THEREFORE ASKED FOR PLATE TO BE REMOVED. DURING REMOVAL IT WAS FOUND THAT THE MAXILLA PLATE HAD BROKEN ON TWO LOCATIONS.
Patient problems: Swelling/ Edema
MAUDE report 15103183 ↗InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAS AN INFECTION IN THE AREA OF THE MAXILLA PLATE.
Patient problems: Unspecified Infection
MAUDE report 13863206 ↗InjuryFeb 25, 2022Fracture; Fracture
MAXILLA PLATE BROKE IN TWO LOCATIONS AND WILL BE REMOVED.
Patient problems: Difficulty Chewing; Implant Pain; Insufficient Information
MAUDE report 13597531 ↗InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NECROSIS AFTER IMPLANTATION OF MAXILLA PLATE. PLATE WAS REMOVED.
Patient problems: Necrosis
MAUDE report 12785746 ↗InjuryAug 31, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information
SURGEON REPORTED AN ISSUE WITH THE MAXILLA PLATE POST-OPERATIVELY AND THE NEED FOR REMOVAL OF THE PLATE.
Patient problems: Erosion; Insufficient Information
MAUDE report 12390505 ↗InjuryAug 31, 2021Fracture; Fracture
SURGEON REPORTED A PARTIAL FRACTURE AND FAILURE OF THE MAXILLA PLATE POST-OPERATIVELY.
Patient problems: Implant Pain; Insufficient Information
MAUDE report 12390503 ↗InjuryAug 31, 2021Fracture; Fracture
SURGEON REPORTED A FRACTURE OF THE MAXILLA PLATE POST-OPERATIVELY.
Patient problems: Difficulty Chewing; Insufficient Information
MAUDE report 12390502 ↗InjuryJun 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT EXPERIENCED SKIN PAIN ON LOCATION OF MAXILLA PLATE AND IT WAS DECIDED TO EXPLANT THE PLATE.
Patient problems: Implant Pain
MAUDE report 12006974 ↗InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION SURGERY OF LEFT MAXILLA BECAUSE OF AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 11670082 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K170272. One submission often covers many models, so check the product and lot details in each record.
- Z-1484-2020 · Feb 3, 2020 · TerminatedTRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001
- Z-1485-2020 · Feb 3, 2020 · TerminatedTRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Other Plate, Bone devices
- MatrixNEURO 04.503.104.01Synthes GmbH · PLATE, BONE252 reports
- RapidSorb 806.004.02SSynthes GmbH · PLATE, BONE146 reports
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.