TRUMATCH SD980.108Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05420060381089), received between Oct 13, 2021 and Dec 11, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Fracture” (3 reports).

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

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TAKEN TO X-RAY A DAY AFTER IMPLANTATION OF A PERSONALIZED IMPLANT WHEN A FRACTURE ON A RIGHT SIDE OF MANDIBLE BONE WAS NOTICED. A REPLACEMENT SURGERY WILL BE PLANNED.

  Patient problems: Bone Fracture(s)

  MAUDE report 19238871 ↗
• InjuryFeb 23, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 24TH OF JANUARY 2024 MATERIALISE WAS NOTIFIED THAT A PERSONALIZED MANDIBLE IMPLANT HAD EXPOSURE (COMING OUT THROUGH THE SOFT TISSUE), THE SCREW BECAME LOOSE WHICH RESULTED IN IMPLANT POSITIONING BEING SLIGHTLY OFF IN THE INTERIOR PART OF THE IMPLANT. THE SURGEON HAS REQUESTED A NEW IMPLANT.

  Patient problems: Erosion

  MAUDE report 18766256 ↗
• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS A LOW GRADE PERSISTING INFECTION. INFECTION RESULTING IN NEED FOR LEFT SIDE IMPLANT REMOVAL AND REPLACEMENT WITH A NEW IMPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 18631537 ↗
• InjuryAug 17, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  MANDIBLE IMPLANT WORE THROUGH PATIENT'S SKIN AND WAS PARTIALLY REMOVED. REMAINDER OF IMPLANT PLANNED TO BE REMOVED.

  Patient problems: Difficulty Chewing

  MAUDE report 15238846 ↗
• InjuryApr 13, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  MANDIBULAR IMPLANT HAS LOOSENED AND NEEDS TO BE FIXATED AGAIN.

  Patient problems: Implant Pain

  MAUDE report 14099138 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS AN INFECTION AND IMPLANT NEEDS TO BE REMOVED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 14098902 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT IS BEING REMOVED AND PATIENT REQUIRES A NEW RECONSTRUCTION.

  Patient problems: Insufficient Information

  MAUDE report 13867655 ↗
• InjuryMar 23, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  MANDIBLE IMPLANT CAME LOOSE DUE TO LOOSENING OF DEPUY SYNTHES SCREWS. MANDIBLE IMPLANT WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 13863133 ↗
• InjuryOct 13, 2021Fracture; Fracture

  MANDIBLE IMPLANT BROKE AS BONE GRAFT DISAPPEARED OVER TIME. IMPLANT HAS BEEN REPLACED.

  Patient problems: Implant Pain

  MAUDE report 12621570 ↗