TruMatch SD980.016Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 05420060380167), received between Mar 5, 2019 and Apr 22, 2026 — classified as 55 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (21 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 25 most recent of 55 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT'S OCCLUSION CHANGED POST-OPERATIVELY, IT WAS OPENED ANTERIORLY. THE ADDITIONAL SURGICAL INTERVENTION IS NEEDED TO CORRECT THE OCCLUSION.

  Patient problems: Difficulty Chewing

  MAUDE report 24950674 ↗
• InjuryFeb 13, 2026Break

  IT WAS REPORTED THAT THE MANDIBLE PLATE BROKE POSTOPERATIVELY. THE ADDITIONAL SURGICAL INTERVENTION IS NEEDED TO REMOVE THE PLATE.

  Patient problems: Difficulty Chewing

  MAUDE report 24333424 ↗
• InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON HAS REPORTED THAT THE PATIENT NEEDS REVISION SURGERY AS THE BONES AREN'T HEALED AND MANDIBLE PLATES WERE INFECTED AND EXPOSED.

  Patient problems: Malunion of Bone

  MAUDE report 22140295 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD LOSS OF ANATOMICAL ALIGNMENT AFTER FRACTURE REDUCTION. THE REVISION SURGERY IS PLANNED.

  Patient problems: Difficulty Chewing

  MAUDE report 20471382 ↗
• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON HAS REPORTED THAT A PATIENT WAS DEVELOPING A GRANULOMA ON THE MANDIBLE POST-OPERATIVELY AFTER THE USE OF MATERIALISE PERSONALIZED PLATE.

  Patient problems: Granuloma

  MAUDE report 20351659 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  6 WEEKS POST-OPERATIVELY, PATIENT PRESENTED WITH A MALOCCLUSION, AN AOB (ANTERIOR OPEN BITE). 2ND SURGERY NEEDED TO CORRECT THIS BY REVISING THE BSSO.

  Patient problems: Physical Asymmetry

  MAUDE report 19508749 ↗
• InjuryApr 16, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION IN THE LEFT BSSO POST-OPERATIVELY AND REQUIRED ADDITIONAL INTERVENTION ON THE LOWER JAW.

  Patient problems: Unspecified Infection

  MAUDE report 19114683 ↗
• InjuryApr 15, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION IN THE BSSO POST-OPERATIVELY AND REQUIRED ADDITIONAL INTERVENTION ON THE LOWER JAW.

  Patient problems: Unspecified Infection

  MAUDE report 19105465 ↗
• InjuryMar 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT BONE DID NOT FULLY HEAL POST-OPERATIVELY AND AN ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED TO REMOVE ALL HARDWARE FROM THE PATIENT.

  Patient problems: Malunion of Bone

  MAUDE report 18959648 ↗
• InjuryMar 21, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT ENCOUNTERED A RELAPSE POSTOPERATIVELY RESULTING IN A MALOCCLUSION AND REQUIRING A REVISION SURGERY FOR THE LOWER JAW.

  Patient problems: Physical Asymmetry

  MAUDE report 18950971 ↗
• InjuryMar 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ABOUT AN INFECTION ON THE LEFT SIDE OF THE PATIENT'S MANDIBLE. THE PERSONALISED PLATE WAS REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 18934839 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT IS DEVELOPING A GRANULOMA ON MANDIBLE RIGHT SIDE, TWO MONTHS POST SURGERY USING MATERIALISE PERSONALIZED PLATES.

  Patient problems: Granuloma

  MAUDE report 18650209 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED ABOUT PAIN POST SURGERY. SURGEON DETERMINED THE JAW TO BE INSTABLE AND A REVISION SURGERY WAS PERFORMED.

  Patient problems: Difficulty Chewing

  MAUDE report 18544898 ↗
• InjuryDec 21, 2023No Apparent Adverse Event; No Apparent Adverse Event

  HARDWARE WAS REMOVED FROM THE PATIENT DUE TO HIS ALLERGY TO METAL.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18373693 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT STARTED CHEWING AFTER THE INITIAL SURGERY AND THE OCCLUSION WAS THROWN OFF.

  Patient problems: Deformity/ Disfigurement; Unspecified Infection

  MAUDE report 18121217 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  7 WEEKS AFTER THE SURGERY PATIENT HAD BEEN DIAGNOSED WITH WOUND DEHISCENCE IN THE REGION OF RIGHT SIDE MANDIBLE PLATE. THE SURGEON HAD FLUSHED THE WOUND AND PRESCRIBED ANTIBIOTICS.

  Patient problems: Wound Dehiscence

  MAUDE report 17701946 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  6 WEEKS AFTER THE SURGERY PATIENT GOT INFECTION ON RIGHT SIDE OF MANDIBLE WHICH WAS FLUSHED AND DRAINAGE WAS INSTALLED UNDER LOCAL ANESTHESIA.

  Patient problems: Skin Infection

  MAUDE report 17701892 ↗
• InjuryMay 4, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  SCREW WITHDRAWAL NOTICED ON PATIENT, DUE TO REPOSITIONING OF OSTEOTOMISED SEGMENTS.

  Patient problems: Insufficient Information

  MAUDE report 16867953 ↗
• InjuryMay 4, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT HAD BITE DERANGEMENT LIKELY DUE TO OSTEOTOMY INTERFERENCE AND POSSIBLE SCREW PULL OUT, DUE TO MASTICATORY LOAD.

  Patient problems: Difficulty Chewing

  MAUDE report 16867884 ↗
• InjuryMay 4, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  A SCREW PULLOUT RIGHT ANTERIOR BSSO PLATE, AND CALLOUS COLLAPSE AT 8 MONTHS.

  Patient problems: Insufficient Information

  MAUDE report 16867837 ↗
• InjuryMay 4, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  A SCREW PULLOUT BILATERAL BSSO PLATES AND OSTEOTOMY COLLAPSE WITH ANTERIOR OPEN BITE AOB.

  Patient problems: Abrasion

  MAUDE report 16867794 ↗
• InjuryDec 12, 2022Fracture; Fracture

  THE PATIENT WAS DOING WELL AND THE BONE WAS HEALED. THE PATIENT CAME BACK LATER FOR CONTROL THE PLATE WAS BROKEN. THERE'S NO INFECTION OR OTHER HARM TO THE PATIENT. REVISION SURGERY PLANNED (B)(6) 2022 TO REMOVE BROKEN PLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15961947 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON NOT SATISFIED WITH OUTCOME AS THE OCCLUSION IS OFF. REVISION SURGERY PLANNED.

  Patient problems: Difficulty Chewing; Physical Asymmetry

  MAUDE report 15585851 ↗
• InjurySep 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS FEELING DISCOMFORT DUE TO HER BSSO PLATE STICKING OUT PAST HER MANDIBLE. PATIENT WILL NEED REVISION SURGERY TO REMOVE THE PLATE.

  Patient problems: Discomfort

  MAUDE report 15508588 ↗
• InjuryAug 17, 2022Fracture; Fracture

  LEFT BSSO PLATE BROKE AFTER APPROXIMATELY 8 MONTHS AND WILL BE REPLACED WITH NEW BSSO PLATE.

  Patient problems: Difficulty Chewing

  MAUDE report 15238847 ↗

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