TruMatch SD980.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05420060380204), received between May 18, 2018 and Dec 11, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Fracture” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryAug 14, 2025Break; Break

  THE SURGEON HAS REPORTED THAT THE PLATE HAS BROKEN POST-OPERATIVELY.

  Patient problems: Difficulty Chewing

  MAUDE report 22805040 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH PERSISTENT SWELLING AND OSTEOMYELITIS/INFECTION. SURGEONS REVIEWED CT SCANS AND SEE SOME BONE DEGRADATION AND LOOSE SCREWS. SURGEONS SUSPECT THAT THE PATIENT DID NOT HEAL WELL FROM THE ORIGINAL SURGERY AND THE INFECTION CAME FIRST AND CAUSED THE LOOSE SCREWS (BUT THERE IS NO WAY TO TELL). PATIENT ALSO HAS TYPE II DIABETES WHICH THEY THINK WAS A CONTRIBUTING FACTOR. EXISTING PLATE WILL BE REMOVED, FIBULA AND RAMUS SEGMENT SLIGHTLY REPOSITIONED AND THEN NEW MILLED PLATE PUT ON.

  Patient problems: Osteomyelitis

  MAUDE report 15585853 ↗
• InjuryMay 25, 2022Fracture; Fracture

  MANDIBLE PLATE BROKE AND HAS TO BE REPLACED.

  Patient problems: Difficulty Chewing; Implant Pain

  MAUDE report 14494701 ↗
• InjuryApr 28, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  OCCLUSION WAS OFF AT END OF SURGERY AND PATIENT HAD TO BE PLACED IN IMF TO SECURE IT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11736744 ↗
• InjuryNov 27, 2018Fracture; Fracture

  PLATE FOR MANDIBLE RECONSTRUCTION BROKE AFTER SEVEN MONTHS, REVISION SURGERY IS NEEDED.

  Patient problems: No Code Available

  MAUDE report 8105081 ↗
• InjuryMay 18, 2018Fracture; Physical Property Issue; Fracture; Physical Property Issue

  A PATIENT SPECIFIC PLATE WAS USED TO PERFORM A MANDIBLE RECONSTRUCTION. IT WAS REPORTED THAT THE 3D PRINTED PLATE FOR THIS CASE BROKE AFTER 6 MONTHS. BY THEN THE RECONSTRUCTION HAD ALREADY NICELY HEALED, SO THE SURGEON DIDN'T CONSIDER IT AS A BIG ISSUE AND JUST TOOK IT OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7524881 ↗

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