TruMatch SD980.021Recalls & reported problems
Materialise NV · TRUMATCH Midface/Mandible - Titanium 3D Printed Plate for Mandible, Large · Class 2 · Implant
All models of TruMatch (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05420060380211), received between Jan 13, 2021 and May 29, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Difficulty Chewing2
- Implant Pain1
- Malunion of Bone1
- Pain1
- Skin Tears1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryMay 29, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE SURGEON HAS REPORTED THAT THE PLATE IS LOOSE AND NEEDS TO BE REMOVED.
Patient problems: Malunion of Bone
MAUDE report 22105987 ↗InjuryFeb 6, 2025Break; Break
THE PLATE WAS REPORTED BROKEN AND ADDITIONAL SURGICAL INTERVENTION IS PLANNED TO REMOVE THE DEVICE.
Patient problems: Difficulty Chewing
MAUDE report 21323517 ↗InjuryJul 14, 2022Fracture; Fracture
BROKEN IMPLANT TO BE REMOVED AND PATIENT REQUIRES A NEW RECONSTRUCTION.
Patient problems: Pain
MAUDE report 15010996 ↗InjuryMay 19, 2022Fracture; Fracture
MANDIBLE PLATE BROKE AND NEEDS TO BE REPLACED.
Patient problems: Difficulty Chewing; Implant Pain
MAUDE report 14447353 ↗InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENTS SKIN FLAP ON THE MANDIBLE WAS VERY THIN DUE TO TUMOUR PROXIMITY. SHE HAS NOW DEVELOPED A HOLE IN HER SKIN OVER THE LEFT "BULGE" OF THE IMPLANT. A SKIN GRAPH WILL BE PLACED DURING A NEXT SURGERY.
Patient problems: Skin Tears
MAUDE report 11160581 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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