TruMatchRecalls & reported problems across all models
Materialise NV · 14 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 139
- Deaths reported
- 0
- Injuries reported
- 137
- Recalls
- 2
We found 14 models of TruMatch by Materialise NV in the FDA's device registry (GUDID). Together they are named in 139 adverse event reports in the FDA's MAUDE database, received between Nov 28, 2017 and May 22, 2026 — classified as 137 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (29 reports).
2 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
TruMatch recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 3, 2020Class IITerminated
Custom surgical kits contain a plate different than indicated by the package labeling.
Z-1485-2020 · Root cause: Employee error · Recall details · FDA record ↗
- Feb 3, 2020Class IITerminated
Custom surgical kits contain a plate different than indicated by the package labeling.
Z-1484-2020 · Root cause: Employee error · Recall details · FDA record ↗
Most reported TruMatch problems
Device problems
- Adverse Event Without Identified Device or Use Problem60
- Insufficient Device Problem Information29
- Fracture23
- Device Appears to Trigger Rejection17
- No Apparent Adverse Event7
- Break6
- Loosening of Implant Not Related to Bone-Ingrowth6
- Inadequacy of Device Shape and/or Size3
Patient problems
- Unspecified Infection40
- Difficulty Chewing21
- Physical Asymmetry17
- Insufficient Information11
- Implant Pain9
- No Code Available9
- No Clinical Signs, Symptoms or Conditions6
- Malunion of Bone5
TruMatch models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TruMatch SD980.001Plate, Bone1 recall21 reports
- TruMatch SD980.016Plate, Bone55 reports
- TruMatch SD980.013Plate, Bone1 recall0 reports
- TruMatch SD980.014Plate, Bone20 reports
- TRUMATCH SD980.108Plate, Bone11 reports
- TruMatch SD980.020Plate, Bone9 reports
- TruMatch SD980.021Plate, Bone5 reports
- TruMatch SD980.003Plate, Bone4 reports
- TruMatch SD980.017Plate, Bone4 reports
- TRUMATCH SD980.109Plate, Bone4 reports
- TruMatch SD980.005Plate, Bone3 reports
- TruMatch SD980.011Plate, Bone1 report
- TRUMATCH SD980.107Plate, Bone1 report
- TruMatch SD980.113Plate, Bone1 report
Recent TruMatch adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
PATIENT'S LEFT MAXILLARY IS MOBILE. REVISION SURGERY WILL BE NEEDED.
Patient problems: Malunion of Bone
MAUDE report 25255534 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
PATIENT HAS A MALOCCLUSION POST-OPERATIVELY. REVISION SURGERY WILL BE NEEDED.
Patient problems: Physical Asymmetry
MAUDE report 25241895 ↗InjuryApr 22, 2026Loosening of Implant Not Related to Bone-Ingrowth
THE PATIENT'S OCCLUSION CHANGED POST-OPERATIVELY, IT WAS OPENED ANTERIORLY. THE ADDITIONAL SURGICAL INTERVENTION IS NEEDED TO CORRECT THE OCCLUSION.
Patient problems: Difficulty Chewing
MAUDE report 24950674 ↗InjuryFeb 13, 2026Break
IT WAS REPORTED THAT THE MANDIBLE PLATE BROKE POSTOPERATIVELY. THE ADDITIONAL SURGICAL INTERVENTION IS NEEDED TO REMOVE THE PLATE.
Patient problems: Difficulty Chewing
MAUDE report 24333424 ↗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 ↗InjuryDec 11, 2025Fracture; Fracture
A BROKEN IMPLANT WAS NOTICED DURING PATIENT APPOINTMENT WHICH TOOK A PLACE ON UNKNOWN DAY OF WEEK COMMENCING (B)(6) 2025. A NEW SURGERY WILL TAKE OUT CURRENT PLATE TO REPLACE WITH PSPM PLATE.
Patient problems: Physical Asymmetry
MAUDE report 23778873 ↗InjuryDec 11, 2025Fracture; Fracture
IT WAS REPOTED THAT TITANIUM 3D PRINTED PLATE WAS BROKEN. REVISION SURGERY NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778205 ↗InjuryNov 19, 2025Fracture; Fracture
IT WAS REPORTED THAT MANDIBLE TITANIUM 3D PRINTED PLATE BROKE ON UNKNOWN DATE. REVISION SURGERY NEEDED TO REPLACE BROKEN PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23596892 ↗InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE HARDWARE IS PLANNED TO BE REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23479255 ↗InjuryOct 29, 2025Fracture; Fracture
CMF TI IMPLANT FRACTURED ALMOST 1 YEAR AFTER THE ORIGINAL SURGERY. REVISION SURGERY IS NEEDED TO REPLACE FRACTURED CMF TI IMPLANT, DATE UNKNOWN.
Patient problems: Implant Pain
MAUDE report 23413337 ↗InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAS A MALOCCLUSION AND NON-UNION BETWEEN MAXILLA AND SKULL. REVISION SURGERY IS NEEDED TO CORRECT THE OCCLUSION.
Patient problems: Physical Asymmetry
MAUDE report 23066557 ↗InjuryAug 14, 2025Break; Break
THE SURGEON HAS REPORTED THAT THE PLATE HAS BROKEN POST-OPERATIVELY.
Patient problems: Difficulty Chewing
MAUDE report 22805040 ↗InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SURGERY WAS COMPLETED AS USUAL BUT POST-OPERATION WAS NOT AS EXPECTED. THE PATIENT HAS A CLASS 2 OCCLUSION INSTEAD OF PLANNED CLASS 1 OCCLUSION. REDO SURGERY NEEDED TO CORRECT OCCLUSION.
Patient problems: Physical Asymmetry
MAUDE report 22461588 ↗InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SURGEON HAS REPORTED THAT THE PATIENT NEEDS REVISION SURGERY AS THE BONES AREN'T HEALED AND MANDIBLE PLATES WERE INFECTED AND EXPOSED.
Patient problems: Malunion of Bone
MAUDE report 22140295 ↗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 ↗
Other Materialise NV products
All Materialise NV devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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