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TruMatch SD980.005Recalls & reported problems

Materialise NV · TRUMATCH Orthognathics - Full Maxillary Surgical Kit · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05420060380051), received between Sep 24, 2019 and Dec 28, 2022 — classified as 3 injuries.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem3

Patient problems

  • No Code Available1
  • Pain1
  • Physical Asymmetry1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    POST-OP OCCLUSION NOT AS PLANNED. SURGEON INTENDS TO DO REVISION SURGERY AT SOME POINT.

    Patient problems: Physical Asymmetry

    MAUDE report 16058941 ↗
  • InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT EXPERIENCED PAIN SINCE (B)(6) 2019 AND THEREFORE REVISION SURGERY WAS DONE ON (B)(6) 2019; DURING THIS SURGERY IT WAS FOUND THAT A SECTION OF THE MAXILLA PLATE WAS BROKEN.

    Patient problems: Pain

    MAUDE report 9320833 ↗
  • InjurySep 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    SURGEON REPORTED THAT REVISION SURGERY WAS NEEDED AS THE FINAL OUTCOME DID NOT MEET THE PLANNED OUTCOME WITH REGARDS TO THE OCCLUSION.

    Patient problems: No Code Available

    MAUDE report 9108804 ↗

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-1485-2020 · Feb 3, 2020 · Terminated
    TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
  • Z-1484-2020 · Feb 3, 2020 · Terminated
    TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001

Other Plate, Bone devices

All Plate, Bone devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.