MatrixMIDFACE 04.503.225.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10887587019147), received between Aug 31, 2018 and Sep 12, 2025 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (17 reports).

2 other recalls cover devices cleared under the same FDA submission (K050608, K083388); 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2025Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SCREWS WERE RETAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23037228 ↗
• MalfunctionSep 12, 2025Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE SCREWS WERE RETAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23037226 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWS HEADS WERE BROKEN DURING ORTHOGNATHIC JAW SURGERY. FRAGMENTS WERE GENERATED BUT THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A FIFTEEN MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897616 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWS HEADS WERE BROKEN DURING ORTHOGNATHIC JAW SURGERY. FRAGMENTS WERE GENERATED BUT THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A FIFTEEN MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897615 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWS HEADS WERE BROKEN DURING ORTHOGNATHIC JAW SURGERY. FRAGMENTS WERE GENERATED BUT THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A FIFTEEN MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897614 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWS HEADS WERE BROKEN DURING ORTHOGNATHIC JAW SURGERY. FRAGMENTS WERE GENERATED BUT THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A FIFTEEN MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897613 ↗
• MalfunctionAug 26, 2025Break; Break

  IT WAS REPORTED THAT THE SCREWS HEADS WERE BROKEN DURING ORTHOGNATHIC JAW SURGERY. FRAGMENTS WERE GENERATED BUT THEY WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THERE WAS A FIFTEEN MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897610 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, A MIDFACE SCREW BROKE IN A CASE. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20659198 ↗
• MalfunctionJun 3, 2024Break; Break

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. DURING THE SURGERY, WHEN INSERTING THE SCREW, THE SCREW WAS BROKEN. ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS NO SURGICAL DELAY. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19450851 ↗
• InjuryApr 3, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS IMPLANTING A 5MM MIDFACE SCREW INTO THE ZYGOMA AND THE THREADED PORTION OF THE SCREW BROKE OFF FROM THE HEAD OF THE SCREW. TWO (2) OUT OF THE MATRIX MIDFACE SET BROKE OFF DURING THE SURGERY. THE BOTTOM OF THE SCREW REMAINED IN THE PATIENT. ANOTHER REMB DRILL WAS NEEDED FOR THE PROCEDURE. THE SURGEON HAD TO DRILL AT A DIFFERENT ANGLE AND PUT IN ANOTHER SCREW. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. CONCOMITANT DEVICES REPORTED: TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM (PART NUMBER 04.503.225.01, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9923367 ↗
• InjuryApr 3, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON WAS IMPLANTING A 5MM MIDFACE SCREW INTO THE ZYGOMA AND THE THREADED PORTION OF THE SCREW BROKE OFF FROM THE HEAD OF THE SCREW. TWO (2) OUT OF THE MATRIX MIDFACE SET BROKE OFF DURING THE SURGERY. THE BOTTOM OF THE SCREW REMAINED IN THE PATIENT. ANOTHER REMB DRILL WAS NEEDED FOR THE PROCEDURE. THE SURGEON HAD TO DRILL AT A DIFFERENT ANGLE AND PUT IN ANOTHER SCREW. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. CONCOMITANT DEVICES REPORTED: TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM (PART NUMBER 04.503.225.01, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9923366 ↗
• MalfunctionSep 6, 2019Break; Break

  DEVICE REPORT FROM SYNTHES CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING THE PROCEDURE FIVE (5) SCREWS BROKEN. IT WAS NOTED THAT A PORTION OF THE BROKEN SCREW REMAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: SCREWDRIVER SHAFT (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1); MATRIX SCREWDRIVER HANDLE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A TI MATRIXMID FACE SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4). ADDITIONAL DEVICES ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8969587 ↗
• MalfunctionSep 6, 2019Break; Break

  DEVICE REPORT FROM SYNTHES CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING THE PROCEDURE FIVE (5) SCREWS BROKEN. IT WAS NOTED THAT A PORTION OF THE BROKEN SCREW REMAINED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: SCREWDRIVER SHAFT (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1); MATRIX SCREWDRIVER HANDLE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4). ADDITIONAL DEVICES ARE CAPTURED ON RELATED COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8969571 ↗
• MalfunctionSep 5, 2019Break; Break

  ON (B)(6) 2019 SALES REP CONFIRMED THAT THE SCREWS WERE BREAKING AND WAS STUCK IN THE PATIENT. THEREFORE, IT CAN'T BE RETURNED OR IT WAS DISCARDED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 8966842 ↗
• MalfunctionSep 5, 2019Break; Break

  ON (B)(6) 2019 SALES REP CONFIRMED THAT THE SCREWS WERE BREAKING AND WAS STUCK IN THE PATIENT. THEREFORE, IT CAN'T BE RETURNED OR IT WAS DISCARDED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 8966830 ↗
• MalfunctionSep 5, 2019Break; Break

  SALES REP CONFIRMED ON (B)(6) 2019 THAT THE SCREWS WERE BREAKING AND WAS STUCK IN THE PATIENT. THEREFORE, IT CAN'T BE RETURNED OR IT WAS DISCARDED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 8966814 ↗
• MalfunctionAug 29, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING ON A ZYGOMATICOMAXILLARY COMPLEX FRACTURE PROCEDURE, WHILE THE SURGEON WAS SCREWING THE TITANIUM MATRIXMIDFACE SCREWS SELF-DRILLING INTO AN UNKNOWN 8 MM ORBITAL RIM PLATE, AS THE SCREWS SELF-DRILLING WAS CLOSE TO COMPLETION, A PIECE OF THE SCREWS SELF-DRILLING CHIPPED OFF. THE SALES CONSULTANT HAD THE LITTLE PIECE OF THE SCREW HEAD AND A VERY SMALL FRAGMENT. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SELF-DRILLING SCREWS. FRAGMENTS GENERATED FROM A BROKEN DEVICE AND WERE REMOVED. THERE WAS NO SURGICAL DELAY. SURGERY SUCCESSFULLY COMPLETED. PATIENT OUTCOME COMPLETED. CONCOMITANT DEVICES REPORTED: UNK - PLATES: MATRIX ORBITAL (PART # UNKNOWN; LOT # UNKNOWN; QUANTITY 1). THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE SCREW SELF-DRILLING 5 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8945316 ↗
• MalfunctionAug 31, 2018Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT UNDERWENT CRANIOPLASTY ON (B)(6) 2018. DURING THE PROCEDURE THERE WERE TWO SETS OF TITANIUM MATRIXMIDFACE SELF DRILLING SCREWS AVAILABLE IN THE PROCEDURE SET THAT WAS PREPARED BY THE FACILITY, EACH SET HAS A QUANTITY OF 80 SCREWS. ONE SET WAS OPENED DURING THE SURGERY. THE SURGEON ATTEMPTED TO USE 20 SCREWS FROM THE SET, BUT THEY WERE ALL NOTED TO BE DULL AND HAD DIFFICULTY PUTTING THE SCREWS INTO THE SKULL. THE SURGEON THEN SWITCHED TO THE MATRIX NEURO SET AND WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE 4MM SCREWS WITHOUT DIFFICULTY. THERE WAS A 20 MINUTES DELAY IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE. DURING MANUFACTURER¿S PRELIMINARY ANALYSIS OF THE RETURNED DEVICE IT WAS OBSERVED THAT THE SCREW IS BENT. THIS DEVICE CONDITION WAS RE-EVALUATED AND DETERMINED TO BE REPORTABLE ON (B)(6) 2018. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE SCREW SELF-DRILLING 5MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7837286 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050608, K083388. One submission often covers many models, so check the product and lot details in each record.

• Z-2739-2020 · Jun 16, 2020 · Terminated
  MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive proced
• Z-2272-2015 · Jun 24, 2015 · Terminated
  Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixati