TruMatch SD980.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05420060380037), received between Apr 26, 2019 and May 28, 2025 — classified as 4 injuries.

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

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

• InjuryMay 28, 2025Fracture; Fracture

  SURGERY OF THIS CASE WENT WELL, MAXILLA WAS IN CORRECT POSITION RIGHT AFTER SURGERY. DURING FOLLOW UP APPOINTMENT SOME WEEKS LATER IT WAS DISCOVERED THAT THE MAXILLA MOVED POSTERIORLY AND UPWARDS WHICH LEAD TO A BAD OCCLUSION. IN THE SCAN IT WAS NOTICED THAT THE MAXILLA PLATE HAD MOVED POSTERIOR INTO THE SINUS AND THE MEDIAL LINK OF THE PLATE ON THE LEFT SIDE BROKE. ALSO ALMOST ALL SCREWS IN THE UPPER SKULL DISLOCATED FROM THE PLATE. REVISION SURGERY PLANNED FOR 10 JUNE 2025.

  Patient problems: Physical Asymmetry

  MAUDE report 22095134 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WHEN THE PATIENT WAS RELEASED FROM IMF, THE MANDIBLE AND THE OCCLUSION SAGGED BACK SO THE PATIENT ENDED UP WITH A BIGGER OVER JET THAN WE PLANNED, AND PREMATURE CONTACT CAUSED OPEN BITE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17929850 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS ANTERIOR OPEN BITE AND IS UNABLE TO CHEW. NEEDS REVISION SURGERY.

  Patient problems: Difficulty Chewing

  MAUDE report 15585852 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT A BI-SAGITTAL SPLIT OSTEOTOMY OF THE MANDIBLE. POST-OPERATIVE IT APPEARED THE OCCLUSION DID NOT MATCH THE PLANNED OUTCOME, WHILE DURING SURGERY NO OCCLUSION DISCREPANCIES WERE DETECTED. THE PATIENT NEEDS REVISION SURGERY, SURGERY NOT YET PLANNED.

  Patient problems: No Code Available

  MAUDE report 8554420 ↗

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