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TRUMATCH SD980.109Recalls & reported problems

Materialise NV · TRUMATCH TI Implant - Mandible - large · Class 2

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05420060381096), received between Jan 19, 2021 and Aug 25, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

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 Problem2
  • Fracture1
  • Insufficient Device Problem Information1
  • Migration1
  • Patient Device Interaction Problem1

Patient problems

  • Fistula1
  • Foreign Body Reaction1
  • No Clinical Signs, Symptoms or Conditions1
  • Nonunion/Delayed-union Bone Fracture1
  • Wound Dehiscence1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 25, 2023Fracture; Fracture

    THE IMPLANT BROKE 4 WEEKS AFTER INITIAL SURGERY. A REVISION SURGERY IS REQUIRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions; Nonunion/Delayed-union Bone Fracture

    MAUDE report 17623488 ↗
  • InjuryJan 3, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

    WE HAVE RECEIVED FEEDBACK FROM SURGEON ABOUT THE EXPOSED TRUMATCH CMF IMPLANT. THE SURGEON PLACED THE IMPLANT AND PACKED IT WITH PARTICULATED BONE. AT THE 2 WEEKS POST-OP CONSULTATION THE HEALING WAS GOING WELL, BUT BY WEEK 3.5-4 THERE WAS A FISTULATION ON THE FLOOR OF THE MOUTH. ANOTHER SURGERY IS PLANNED AS A REDO SURGERY FOR WHICH THE PATIENT WILL BE IMPLANTED WITH A STANDARD PLATE; THE PATIENT WILL BE OPERATED ON (B)(6) 2022.

    Patient problems: Fistula

    MAUDE report 16090978 ↗
  • InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT REJECTED MANDIBLE IMPLANT WHICH HAD TO BE REMOVED. IMPLANT REJECTION WAS CAUSED BY PATIENT CONDITION ACCORDING TO SURGEON.

    Patient problems: Foreign Body Reaction

    MAUDE report 15326021 ↗
  • InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Migration

    MANDIBLE IMPLANT WAS WEARING THROUGH THE PATIENTS SOFT TISSUE AND WAS EXPLANTED.

    Patient problems: Wound Dehiscence

    MAUDE report 11192717 ↗

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.