TruMatch SD980.017Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05420060380174), received between May 9, 2019 and Jan 13, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K170272, K243637); 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.

• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANDIBLE SAGGITAL SPLIT CUT HAS DAMAGED THE NERVE.

  Patient problems: Insufficient Information; Nerve Damage

  MAUDE report 11160597 ↗
• InjuryMay 14, 2019Device Appears to Trigger Rejection; Insufficient Device Problem Information; Device Appears to Trigger Rejection; Insufficient Device Problem Information

  THE PATIENT UNDERWENT A BI-SAGITTAL SPLIT OSTEOTOMY OF THE MANDIBLE. POST-OPERATIVE AN INFECTION WAS REPORTED ON ONE SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 8607130 ↗
• InjuryMay 14, 2019No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  THE PATIENT UNDERWENT A BI-SAGITTAL SPLIT OSTEOTOMY OF THE MANDIBLE. POST-OPERATIVE AN INFECTION WAS REPORTED ON ONE SIDE.

  Patient problems: No Known Impact Or Consequence To Patient; Unspecified Infection

  MAUDE report 8607117 ↗
• InjuryMay 9, 2019Use of Device Problem; Use of Device Problem

  SURGEON CLAIMS THE FIT OF THE GUIDE WAS NOT UNIQUE, RESULTING IN A SURGERY DELAY OF 2 HOURS. MULTIPLE DRILLING WAS DONE. PATIENT COMPLAINTS A HYPOESTESIA ALONG THE FIELD OF INNERVATION OF THE LEFT INFERIOR ALVEOLAR NERVE.

  Patient problems: Hypoesthesia

  MAUDE report 8594217 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170272, K243637. 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