TruMatch SD980.001Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05420060380013), received between Nov 28, 2017 and May 22, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 FDA recall record name this device's identifier.

1 other recall 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.

Recalls naming this device

1. Feb 3, 2020Terminated

   Custom surgical kits contain a plate different than indicated by the package labeling.

   Z-1484-2020 · Root cause: Employee error · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT'S LEFT MAXILLARY IS MOBILE. REVISION SURGERY WILL BE NEEDED.

  Patient problems: Malunion of Bone

  MAUDE report 25255534 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT HAS A MALOCCLUSION POST-OPERATIVELY. REVISION SURGERY WILL BE NEEDED.

  Patient problems: Physical Asymmetry

  MAUDE report 25241895 ↗
• InjurySep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS A MALOCCLUSION AND NON-UNION BETWEEN MAXILLA AND SKULL. REVISION SURGERY IS NEEDED TO CORRECT THE OCCLUSION.

  Patient problems: Physical Asymmetry

  MAUDE report 23066557 ↗
• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGERY WAS COMPLETED AS USUAL BUT POST-OPERATION WAS NOT AS EXPECTED. THE PATIENT HAS A CLASS 2 OCCLUSION INSTEAD OF PLANNED CLASS 1 OCCLUSION. REDO SURGERY NEEDED TO CORRECT OCCLUSION.

  Patient problems: Physical Asymmetry

  MAUDE report 22461588 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON HAS REPORTED THAT MANDIBLE HARDWARE IS BEING REMOVED DUE TO POST-OP COMPLICATIONS.

  Patient problems: Malunion of Bone

  MAUDE report 21125421 ↗
• InjuryOct 4, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE IMPLANT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20370043 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  BSSO PLATES REMOVED DUE TO PATIENT'S MANDIBLE AS BEING ASYMMETRIC WITH SUBOPTIMAL OCCLUSION.

  Patient problems: Physical Asymmetry

  MAUDE report 17077810 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT COMPLAINED OF ACUTE SWELLING ON RIGHT CHEEK. HE WAS ADMITTED FOR ANTIBIOTICS AND EUA. THE RIGHT PLATE WAS REMOVED AND PLACED BACK WITH LARGER SCREWS. JUST BEFORE OPERATION THE PATIENT COMPLAINTED THAT HIS LEFT SIDE IS ALSO BECOMING SORE. THE SAME OPERATION WILL LIKELY BE DONE ALSO ON THE LEFT SIDE.

  Patient problems: Sinusitis

  MAUDE report 16396086 ↗
• InjuryFeb 7, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information

  TRUMATCH MAXILLARY PLATE DID NOT FIT PATIENT ANATOMY. THE PLANNED ADVANCEMENT WAS NOT REACHED. REVISION SURGERY NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311134 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  8 WEEKS AFTER OPERATION THE PATIENT SUFFERED SWELLING IN LEFT BSSO REGION. DURING REVISION ON (B)(6) 2022 SURGEON REPLACED SCREWS WITH THICKER SCREWS.

  Patient problems: Swelling/ Edema

  MAUDE report 16142039 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS A RETRUDED MANDIBLE WITH AN ANTERIOR OVERBITE AFTER SURGERY.

  Patient problems: Physical Asymmetry

  MAUDE report 14050016 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MAXILLA HAS BECOME MOBILE AND PATIENT WILL REQUIRE REVISION SURGERY TO PLACE NEW PLATE.

  Patient problems: Difficulty Chewing; Insufficient Information

  MAUDE report 12960752 ↗
• InjuryOct 27, 2021Positioning Problem; Positioning Problem

  FINAL OCCLUSION OUTCOME NOT AS PLANNED. REVISION REQUIRED.

  Patient problems: Insufficient Information; Physical Asymmetry

  MAUDE report 12702820 ↗
• InjuryNov 4, 2020Difficult or Delayed Positioning; Inadequacy of Device Shape and/or Size; Difficult or Delayed Positioning; Inadequacy of Device Shape and/or Size

  AFTER THE SURGERY, IT WAS FOUND THAT THE OCCLUSION WAS OFF AND THAT THIS RESULTED IN THE PATIENT HAVING AN OVER BITE. SURGEON IS DISCUSSING WITH PATIENT WHETHER TO HAVE A REVISION SURGERY OR NOT.

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

  MAUDE report 10788165 ↗
• InjuryAug 6, 2020Malposition of Device; Malposition of Device

  REVISION SURGERY NEEDED AS MANDIBLE DID NOT ADVANCE AS PLANNED AND CAUSED THE OCCLUSION TO BE OFF.

  Patient problems: No Code Available

  MAUDE report 10371927 ↗
• InjuryAug 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY BECAUSE THE DAY AFTER THE PRIMARY SURGERY, THE X-RAY SHOWED A POSTERIOR OPEN BITE AND MIDLINE SHIFT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 10371926 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-OP IMAGES SHOWED THAT CONDYLES WERE OUT OF THE FOSSA. THEREFORE REVISION SURGERY WILL BE NEEDED.

  Patient problems: No Code Available

  MAUDE report 9841234 ↗
• InjuryFeb 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY NEEDED BECAUSE SCREWS BACKING OUT OF THE PLATE.

  Patient problems: Failure of Implant

  MAUDE report 9710934 ↗
• InjuryNov 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON ACCIDENTALY CUT THE NERVE WHEN COMPLETING THE LEFT VENTRAL CUT ON THE MANDIBLE. PATIENT IS DOING WELL. SURGEON SAID THAT PROBABLY THE LIP WILL BE PERMANENTLY PARALYZED. HOWEVER, IT IS POSSIBLE THAT THE PATIENT REGAINS SOME FEELING. THEY WILL HAVE A SECOND SURGERY TO TAKE OUT THE PLATES IN MARCH WHERE THEY WILL REASSESS THE NERVE DAMAGE WITH A NEUROLOGIST.

  Patient problems: Facial Nerve Paralysis

  MAUDE report 9287120 ↗
• MalfunctionOct 2, 2019Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem; Patient Device Interaction Problem; Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem; Patient Device Interaction Problem

  CORRECT GUIDE BUT INCORRECT MAXILLA PLATE WAS PROVIDED TO THE SURGEON AND THEREFORE COULD NOT BE USED. THE SURGICAL PROCEDURE NEEDED TO BE CHANGED DURING SURGERY. REVISION SURGERY MAY BE NEEDED.

  Patient problems: No Code Available

  MAUDE report 9144512 ↗
• InjuryNov 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT BSSO USING TRUMATCH IN (B)(6) 2017. THERE WERE NO ISSUES DURING THE FIRST IMPLANTATION. PATIENT WAS REVISED IN (B)(6) 2017 BECAUSE SURGEON WANTED TO REALIGN THE SEGMENT. IT WAS REPORTED THE ISSUE WAS NOT DUE TO A PRODUCT ISSUE. SURGEON REPORTED IT MAY HAVE BEEN RELATED TO SURGICAL TECHNIQUE.

  Patient problems: No Code Available

  MAUDE report 7062934 ↗

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-1485-2020 · Feb 3, 2020 · Terminated
  TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013