MatrixMIDFACE 03.503.202Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10887587012513), received between Aug 29, 2018 and Mar 28, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE MATRIX SET DRIVERS APPEAR TO BE DULLING AT THE TIP (REDACTED). NO PATIENT INVOLVEMENT AND NO LOT NUMBER AVAILABLE. NO PATIENT INVOLVEMENT,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21726243 ↗
• MalfunctionMar 13, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SETS WERE CONSIGNED AT THE HOSPITAL FOR MORE THAN FEW YEARS. INSTRUMENTS ARE OLD, WORN OFF. DEPTH GAUGE WAS BENT AND GIVING WRONG READINGS. THERE WAS NO PATIENT INVOLVEMENT OR SURGICAL DELAY. EVENT DATE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21597402 ↗
• MalfunctionJan 12, 2024Break; Break

  THE DEPTH GAUGE IS DIFFICULT TO USE AND TO REACH THE CORTICES OF THE BONE. NO FRAGMENTS WERE GENERATED. PATIENT STATUS/ OUTCOME / CONSEQUENCES : NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502303 ↗
• MalfunctionJan 12, 2024Break; Break

  THE DEPTH GAUGE IS DIFFICULT TO USE AND TO REACH THE CORTICES OF THE BONE. NO FRAGMENTS WERE GENERATED.. PATIENT STATUS/ OUTCOME / CONSEQUENCES : NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502301 ↗
• MalfunctionJan 12, 2024Break; Break

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE INSTRUMENTS IN QUESTION WERE FOUND TO BE BROKEN DURING AN UNKNOWN CASE. THERE WAS NO REPORTED SURGICAL DELAY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/76. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502300 ↗
• MalfunctionJan 11, 2024Break; Break

  NO FRAGMENTS WERE GENERATED, NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO ADVERSE PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18495727 ↗
• MalfunctionMay 24, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE SCREWDRIVER BLADES IN THAT LOAN KIT NEED REPLACING AS THEY WEREN¿T GRABBING THE SCREWS VERY WELL AND ONE DROPPED INTO THE MAXILLA WHICH NEEDED A SCOPE TO GET IT OUT. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT. THERE WERE OTHER MEDICAL INTERVENTION AS A SCOPE WAS USED TO RETRIEVE DROPPED SCREW FROM MAXILLA. NO FRAGMENTS WERE GENERATED . THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1)SCRDRIVER SHAFT MATMIDF MED SELF-HOLDING THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16992808 ↗
• MalfunctionApr 20, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE MIDFACE MEDIUM SCREWDRIVER BLADES HAVE BECOME BLUNT WITH USE AND ARE NOT RETAINING SCREWS AS NORMAL. THERE WAS NO ADVERSE PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A 15 MINUTE DELAY BY USING ANOTHER INSTRUMENT SET. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/76MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16777489 ↗
• MalfunctionApr 18, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, THE MIDFACE MEDIUM SCREWDRIVER BLADES HAVE BECOME BLUNT WITH USE AND ARE NOT RETAINING SCREWS AS NORMAL. THERE WAS NO ADVERSE PATIENT IMPACT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER A 15 MINUTE DELAY BY USING ANOTHER INSTRUMENT SET. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/76MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761247 ↗
• MalfunctionMar 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DEVICES WERE UNABLE TO BE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) MATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/76MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13956919 ↗
• MalfunctionMar 20, 2022Difficult to Remove; Physical Resistance/Sticking

  DEVICE REPORT FROM SYNTHES JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT THERE WAS A REMOVAL SURGERY OF MANDIBLE PERFORMED ON (B)(6) 2022. IN THE SURGERY, THE SCREWDRIVER AND THE HANDLE WERE ATTACHED AND USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, THE SCREWDRIVER AND THE HANDLE WERE STUCK AND COULDN'T BE DETACHED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A SCREWDRIVER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13829934 ↗
• MalfunctionNov 12, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MATRIXMANDIBLE COMBINATION BENDER, MATRIXMANDIBLE SHORT CUT PLATE CUTTER, BONE REDUCTION FORCEPS, MATRIXMANDIBLE SCREWDRIVER BLADE, GRAPHIC CASES FOR MATRIX MIDFACE, INSTRUMENT TRAY FOR MATRIX MIDFACE AND DRILL BIT AND BLADE MODULE FOR MATRIX MIDFACE ARE BROKEN AND OR OLDER THAT DOES NOT FUNCTION WELL FOUND IN THE STORAGE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (10) DEVICES. THIS REPORT IS FOR (1) MATRIXMDF SCRDRVR BLD HEX CPL/S-RETN/76. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12805815 ↗
• MalfunctionAug 29, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING TREATMENT OF A ZYGOMATIC BONE FRACTURE ON (B)(6) 2018, THE MATRIXMIDFACE SCREWDRIVER BLADE DID NOT HOLD THE MATRIXMIDFACE SCREW PROPERLY. PATIENT WAS BEING IMPLANTED WITH ONE (1) MATRIXMIDFACE ZYGOMA PLATE AND UNKNOWN QUANTITY OF 1.55 MM DIAMETER MITRIXMIDFACE SCREWS. ANOTHER SCREWDRIVER BLADE WAS AVAILABLE IN THE OPERATING ROOM TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO SURGICAL DELAY NOTED. PATIENT IS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICE: 1.55 MM MATRIXMIDFACE SCREW (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1) THIS REPORT IS FOR A MATRIXMIDFACE SCREWDRIVER BLD HEX COUPLING/SELF-RETAIN/76 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7828306 ↗