MatrixMIDFACE 04.503.226.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10887587019178), received between Apr 26, 2018 and Sep 2, 2026 — classified as 7 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564749 ↗
• MalfunctionSep 2, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50564616 ↗
• MalfunctionSep 2, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 50564511 ↗
• MalfunctionSep 1, 2026Break; Entrapment of Device

  Patient problems: Foreign Body In Patient

  MAUDE report 50545317 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED WHILE INSERTING THE SCREW, THE HEAD SNAPPED OFF LEAVING PART OF THE SHAFT. THE SURGEON WAS ABLE TO REMOVE THE BROKE PART AND COMPLETE THE SURGERY SUCCESSFULLY WITH A FIVE (5) MINUTE DELAY AND NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24081937 ↗
• MalfunctionOct 10, 2023Break; Entrapment of Device; Break; Entrapment of Device

  THERE WAS A SLIGHT DELAY AS A LONGER PLATE HAD TO BE USED TO SPAN THE SCREW FRAGMENT THAT WAS LEFT IN PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17908240 ↗
• MalfunctionOct 5, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN UNKNOWN SURGERY WAS PERFORMED FOR THE HUMERUS ON (B)(6) 2023. DURING THE SURGERY, THE 8MM SCREW¿S HEAD BROKE WHEN IT WAS TIGHTENED WHILE FIXING THE PLATE. THE HEADS OF TWO ADDITIONAL SCREWS, 6MM TO 4MM, ALSO BROKE OFF. THE SHAFTS REMAINED IN THE PATIENT¿S BODY. THERE IS A POSSIBILITY THAT THE FRONT AND BACK OF THE PLATE WERE INSERTED INCORRECTLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE; THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. IT WAS CONFIRMED THAT THERE WAS NO ALLEGATION AGAINST THE PLATE. THIS REPORT INVOLVES ONE TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17876387 ↗
• MalfunctionNov 9, 2022Break; Break

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, THE SCREW IN QUESTION BROKE DURING INSERTION. ALL FRAGMENTS GENERATED WERE REMOVED SUCCESSFULLY FROM THE PATIENT. THE SURGEON CHANGED TO ANOTHER SCREW OF THE SAME LOT, BUT THE SAME ISSUE HAPPENED AGAIN. AFTER FOUR FAILED ATTEMPTS WITH THE SAME PRODUCT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759045 ↗
• MalfunctionNov 9, 2022Break; Break

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, THE SCREW IN QUESTION BROKE DURING INSERTION. ALL FRAGMENTS GENERATED WERE REMOVED SUCCESSFULLY FROM THE PATIENT. THE SURGEON CHANGED TO ANOTHER SCREW OF THE SAME LOT, BUT THE SAME ISSUE HAPPENED AGAIN. AFTER FOUR FAILED ATTEMPTS WITH THE SAME PRODUCT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759040 ↗
• MalfunctionNov 9, 2022Break; Break

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, THE SCREW IN QUESTION BROKE DURING INSERTION. ALL FRAGMENTS GENERATED WERE REMOVED SUCCESSFULLY FROM THE PATIENT. THE SURGEON CHANGED TO ANOTHER SCREW OF THE SAME LOT, BUT THE SAME ISSUE HAPPENED AGAIN. AFTER FOUR FAILED ATTEMPTS WITH THE SAME PRODUCT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759039 ↗
• MalfunctionNov 9, 2022Break; Break

  DEVICE REPORT FROM CHINA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, THE SCREW IN QUESTION BROKE DURING INSERTION. ALL FRAGMENTS GENERATED WERE REMOVED SUCCESSFULLY FROM THE PATIENT. THE SURGEON CHANGED TO ANOTHER SCREW OF THE SAME LOT, BUT THE SAME ISSUE HAPPENED AGAIN. AFTER FOUR FAILED ATTEMPTS WITH THE SAME PRODUCT, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15759038 ↗
• InjuryOct 19, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, A 1.5 X 6 MM SELF-DRILLING SCREW BROKE WHEN IT WAS BEING INSERTED INTO THE PATIENT. HALF OF IT REMAINED INSIDE THE BONE, BUT WITHOUT ANY DAMAGE. THE OTHER FRAGMENT WAS DISCARDED AS IT WAS SHARP. PROCEDURE WAS COMPLETED WITH A DELAY OF TWENTY (20) MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A TITANIUM (TI) MATRIX MIDFACE SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 10698246 ↗
• InjurySep 17, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR CRANIOPLASTY TO FIX THE MATRIX NEURO SYSTEM WITH PLATES AND SCREWS TO THE PSI PEEK DESIGNED FOR THE PATIENT. DURING THE SURGERY, WHEN TIGHTENING THE SELF-DRILLING SCREW BREAKS AND UNABLE TO EXTRACTED FROM THE DEVICE. ALSO, THE DRILL BIT WAS STOPPING THE SYSTEM AND THE SCREW HAS BROKEN DURING THE FINAL TIGHTENING TIME. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 60 MINUTES DELAY. SOME GENERATED FRAGMENTS ARE REMAINS IN THE PATIENT. THERE WERE NO CONSEQUENCES OF THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATES: MATRIXNEURO (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN DRILL BIT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) . TI MATRIX MIDFACE SCREW SELF-DRILLING 6MM. THIS IS REPORT 1 OF 2 (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 10548105 ↗
• InjurySep 17, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT UNDERWENT FOR CRANIOPLASTY TO FIX THE MATRIX NEURO SYSTEM WITH PLATES AND SCREWS TO THE PSI PEEK DESIGNED FOR THE PATIENT. DURING THE SURGERY, WHEN TIGHTENING THE SELF-DRILLING SCREW BREAKS AND UNABLE TO EXTRACTED FROM THE DEVICE. ALSO, THE DRILL BIT WAS STOPPING THE SYSTEM AND THE SCREW HAS BROKEN DURING THE FINAL TIGHTENING TIME. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 60 MINUTES DELAY. SOME GENERATED FRAGMENTS ARE REMAINS IN THE PATIENT. THERE WERE NO CONSEQUENCES OF THE PATIENT. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATES: MATRIXNEURO (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNKNOWN DRILL BIT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) . TI MATRIX MIDFACE SCREW SELF-DRILLING 6MM. THIS IS REPORT 2 OF 2 (B)(4).

  Patient problems: Injury; No Code Available

  MAUDE report 10548101 ↗
• InjuryOct 8, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON WAS FIXING THE ZMC FRACTURE WITH A MATRIXMIDFACE PLATE AND SCREWS. WHEN FIXING THE THIRD SCREW OF FOURTH, AT THE END OF THE SCREWING, THE SCREW HEAD STARTED TO DISINTEGRATE. THEY WERE NOT ABLE TO REMOVE IT AND LEFT THE SCREW IN THE PATIENT, BURRING THE HEAD OF THE SCREW TO MAKE SURE IT WAS NOT SHARP. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. CONCOMITANT DEVICE REPORTED: UNKNOWN MATRIXMIDFACE PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 9168073 ↗
• InjurySep 6, 2019Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED ON (B)(6) 2019, A MATRIX MIDFACE SCREW SELF-DRILLING CRUMBLED WHILE INSERTING IT. IT REQUIRED TIME TO REMOVE THE OF THE SCREW AND THEN SOMETIME TRIED TO REMOVE THE THREAD ITSELF WHICH DID NOT HAPPEN. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATES: MATRIXMIDFACE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8971187 ↗
• InjuryMar 19, 2019Migration; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A MATRIXMIDFACE SCREW HAD COME LOOSE AND FALLEN OUT OF THE PATIENT THAT HAD A PREVIOUS LEFORTE FIXATION. IT WAS NOTED THE SCREW DID NOT BREAK, BUT IT CAME OUT OF NATIVE BONE, OR PURCHASE HAD NEVER FULLY OCCURRED. THIS REPORT IS FOR A MATRIXMIDFACE SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8433756 ↗
• MalfunctionJan 30, 2019Break; Break

  IT WAS REPORTED THAT DURING A CASE OF A MAXILLA RESECTION WITH FIBULA BONE AS THE FLAP ON (B)(6) 2019, A DRILL BIT WAS USED TO IMPLANT NINE (9) 6MM SCREWS INTO THE BONE. TWO (2) SCREW HEADS POPPED OFF/ BROKE AND THE SCREW SHAFT REMAINED IN THE BONE. IT WAS FURTHER REPORTED THAT THE FIBULA FLAP DIED, AND THE SURGICAL TEAM HAD TO REMOVE IT. THIS WAS DETERMINED TO NOT BE CAUSED BY THE SCREW BREAKING OFF. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A THREE (3) MINUTE DELAY. CURRENT PATIENT STATUS IS UNKNOWN. CONCOMITANT MEDICAL PRODUCT: MATRIX 1.1MM DRILL BIT (PART: 03.503.246, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A TITANIUM (TI) MATRIXMIDFACE SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288460 ↗
• MalfunctionNov 5, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, WHEN THE SURGEON SCREWED THE SELF-DRILLING SCREW IN THE HOLE PREVIOUSLY DONE BY A DRILL BIT, THE SCREW HEAD BROKE AND THE SCREW ITSELF STAYED IN THE BONE. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039827 ↗
• InjuryJul 16, 2018Break; Break

  IT WAS REPORTED THAT DURING A FACIAL FRACTURE PROCEDURE ON AN UNKNOWN DATE, THE SCREW HEADS OF TWO (2) TITANIUM MATRIXMIDFACE SCREWS BROKE DURING FINAL TIGHTENING. THE BROKEN FRAGMENTS WERE REMOVED EASILY. HOWEVER, THE SCREW SHAFT, AS WELL AS A PORTION OF THE SCREW HEADS REMAIN EMBEDDED IN THE PATIENT. A SURGICAL DELAY OF FIVE MINUTES OCCURED AS A RESULT OF THE REMOVAL OF THE PART OF THE BROKEN SCREW HEAD. THERE WAS NO PATIENT HARM. CONCOMITANT DEVICES REPORTED: SCREWDRIVER (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TITANIUM MATRIXMIDFACE SCREW SELF-DRILLING 6MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7691257 ↗
• MalfunctionApr 26, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT HAD AN UNKNOWN PROCEDURE ON (B)(6) 2018. THE SURGEON WENT TO PUT IN A 6MM SELF-DRILLING MATRIX MIDFACE SCREW INTO THE ZYGOMATIC FRONTAL BONE AND THE SCREW HEAD SPLIT INTO TWO PIECES. THERE WAS A DELAY IN SURGERY BY 5 MINUTES BY TRYING TO GET THE BROKEN SCREW OUT OF THE BONE. A NEEDLE DRIVER WAS USED TO MANUALLY REMOVE SCREW FROM PATIENT AND INSERTED A NEW ONE. THE HEAD OF THE SCREW WAS RETRIEVED AND SHAFT WAS RETAINED. THE SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE: 1 QTY, PART NUMBER: 04.503.373, LOT NUMBER UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7464588 ↗

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