TruMatch SD980.113Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05420060381133), received between Nov 16, 2023 and Nov 16, 2023 — classified as 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K170272, K173039); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2023Defective Device; Defective Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN IRELAND AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON NOTED DURING THE CASE THAT THE ANTERIOR PORTION OF THE IMPLANT WHERE THE SCREW HOLES WERE, NEEDED TO BE A MILLIMETER OR SO LONGER ANTERIORLY TO COME OVER THE ORBITAL RIM, AS THE POSTERIOR PART OF THE IMPLANT WAS LIFTING OFF THE ORBITAL FLOOR WHEN THE SCREWS WERE FIXED ANTERIORLY. THIS REPORT INVOLVES ONE (1) UNK - PLATES: TRUMATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18150373 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170272, K173039. 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