MatrixMANDIBLE 03.503.047Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10887587011738), received between Dec 13, 2016 and Sep 16, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Device-Device Incompatibility

  It was reported that the drill guide doesn't screw properly in the plate. There was no patient harm or surgical delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50785940 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, ITEMS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840823 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE; THE ITEMS WERE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840458 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE; THE DRILL GUIDE THREAD WAS BROKEN. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731195 ↗
• MalfunctionAug 6, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE; THE DRILL GUIDE THREAD WAS BROKEN. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731187 ↗
• MalfunctionJul 29, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE THREADED DRILL GUIDE WAS NOT ENGAGING BY THREADS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645081 ↗
• MalfunctionMay 30, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT THE DRILL GUIDE DOESN'T SCREW PROPERLY IN THE PLATE. THREADS SEAMS TO NOT WORKING PROPERLY. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22117588 ↗
• MalfunctionNov 15, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE EVENT HAPPENED DURING INTRA-OP AND THERE WAS NO PATIENT INVOLVEMENT. THE DRILL BIT WAS BENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698259 ↗
• MalfunctionFeb 23, 2024Break; Break

  THERE WAS NO CASE INVOLVEMENT. THE BROKEN ITEM WAS DISCOVERED DURING INSPECTION OF TRUNK STOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18769353 ↗
• MalfunctionAug 10, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, WHILE IN SURGERY MATRIX MANDIBLE DRILL GUIDE THE THREAD BROKE OFF DRILL GUIDE. THERE WAS NO PATIENT INVOLVEMENT AND THE DRILL GUIDE BREAKING DID NOT IMPACT THE OUTCOME OF THE OPERATION. THIS REPORT IS FOR ONE (1) MATRIX MANDIBLE THREADED TROCAR DRILL GUIDE FOR 397.213 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17499772 ↗
• MalfunctionJun 7, 2023Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(4) 2023, ONE OF THE TRANSBUCCAL SETS AT THE HOSPITAL HAD A THREADED DRILL SLEEVE WHICH MAY BE SLIGHTLY BENT, SINCE THE TRANSBUCCAL DRILL BITS WERE NOT FITTING PROPERLY. THE SLEEVE AND DRILL BIT WERE HEATING UP DURING DRILLING, INDICATING FRICTION. A NEW INSTRUMENTS SET WAS OPENED, AND THERE WAS A DELAY OF UNKNOWN LENGTH IN THE PROCEDURE. THIS REPORT INVOLVES ONE MATRIXMANDIBLE THREADED TROCAR DRILL GUIDE FOR 397.213. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17077724 ↗
• MalfunctionOct 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING CLEANING, 3 THREADED DRILL GUIDES WERE SAID TO BE NOT USABLE BECAUSE THE DRILL BITS WOULD NOT PASS SMOOTHLY THROUGH THE SHAFTS (DRILL SLEEVE). THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) MATRIXMANDIBLE THREADED TROCAR DRILL GUIDE FOR 397.213. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697410 ↗
• MalfunctionOct 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING CLEANING, 3 THREADED DRILL GUIDES WERE SAID TO BE NOT USABLE BECAUSE THE DRILL BITS WOULD NOT PASS SMOOTHLY THROUGH THE SHAFTS (DRILL SLEEVE). THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE THREADED TROCAR DRILL GUIDE FOR 397.213. THIS IS REPORT 3 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697314 ↗
• MalfunctionOct 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING CLEANING, 3 THREADED DRILL GUIDES WERE SAID TO BE NOT USABLE BECAUSE THE DRILL BITS WOULD NOT PASS SMOOTHLY THROUGH THE SHAFTS (DRILL SLEEVE). THERE WAS NO PATIENT INVOLVEMENT THIS REPORT IS FOR (1) MATRIXMANDIBLE THREADED TROCAR DRILL GUIDE FOR 397.213. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697264 ↗
• InjuryJul 15, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THAT THE DRILL BIT BENT AND CAUSED BURNS TO THE PATIENT. TWO (2) OTHER DRILL BITS WERE TRIED AND DID NOT BEND BUT HEATED TO A POINT OF CAUSING THE BURNS, UPON INSPECTION IT SEEMS THAT THE DRILL SLEEVE HAS A SLIGHT BEND IN IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE THREADED TROCAR DRILL GUIDE FOR 397.213. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Burn(s)

  MAUDE report 12175943 ↗
• MalfunctionJun 4, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A ROUTINE INSPECTION IN STERILE PROCESSING, TWO SCREWDRIVER BLADES WERE NOTED TO HAVE BENT PLUS THE DRIVE FINS WOULD NOT RETAIN THE SCREWS PROPERLY. ALSO, THE THREADED DRILL GUIDE FOR MATRIX MANDIBLE APPEARED TO HAVE WORN THREADS AND WOULD NOT PROPERLY ENGAGE THE PLATES. THERE WAS NO KNOWN PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MATRIXMANDIBLE THREADED TROCAR DRILL GUIDE FOR 397.213. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939140 ↗
• MalfunctionMay 4, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE TWO (2) TRAYS; MATRIX MANDIBLE AND MATRIX MIDFACE TRAY WERE INSPECTED BECAUSE THE TRAYS HAD FALLEN FROM A SHELF IN THE STERILE PROCESSING DEPARTMENT (SPD). SEVERAL PARTS WERE NOTED TO BE DAMAGED IN THE TRAY. ONE (1) BONE REDUCTION FORCEP HAD A BROKEN FINE TIP, ONE (1) SCREWDRIVER HANDLE WAS BROKEN END CAP IS MISSING, ONE (1) MATRIXMANDIBLE DRILL GUIDE BROKEN TIP DAMAGE ON WHICH THE DRILL BIT WOULD NOT EASILY SLIDING THROUGH, AND ONE (1) T-HANDLE WAS BROKEN SLIDE IS VERY LOOSE. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10020834 ↗
• MalfunctionJul 30, 2019Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, IT WAS NOTICED THAT WHEN THE FIELD STOCKING LOCATION (FSL) SET WAS OPENED, A THREAD AT THE END OF THE MATRIXMANDIBLE THREADED TROCAR DRILL GUIDE  HAVE BEEN BROKEN OFF. IT WAS FOR THE SCREW AND DRILL GUIDE. THERE WAS NO PATIENT INVOLVEMENT.   THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8843563 ↗
• MalfunctionOct 5, 2018Break; Break

  SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE MATRIX MANDIBLE THREADED TROCAR DRILL GUIDE FOR THE NETS WAS BROKEN. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A MATRIXMANDIBLE THREADED TROCAR DRILL GUIDE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7939293 ↗
• MalfunctionDec 13, 2016Break; Break

  IT IS REPORTED THE TIP OF A MATRIX MANDIBLE THREADED TROCAR DRILL GUIDE WAS FOUND TO BE BROKEN OFF. ISSUE WAS DISCOVERED WHILE INSPECTING THE TRAY IN STERILE PROCESSING. NO ISSUES WERE REPORTED WITH THE DEVICE PRIOR TO DISCOVERY. NO PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6171351 ↗