MatrixMIDFACE 04.503.224.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10887587019116), received between Jan 15, 2018 and Apr 1, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2025Use of Device Problem; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED AS FOLLOWS: ON (B)(6) 2022, PATIENT COMPLAINED OF ¿CHRONIC IRRITATION AND TEAR PRODUCTION FROM MEDIAL LEFT LOWER LID.¿ SETS A PLAN FOR ¿RELEASE OF CICATRICIAL ECTROPION WITH SCAR REVISION¿ AND ¿LEFT LOWER LID SCAR RELEASE ECTROPION FROM PRIOR FACIAL FRACTURE REPAIR. ON (B)(6) 2022, OPERATIVE REPORT ON SURGERY AND CICATRICIAL ECTROPION LEFT MEDIAL EYELID DUE, PER COMPLAINTS OF ¿CHRONIC IRRITATION AND TEAR PRODUCTION FROM MEDIAL LEFT LOWER LID.¿ ON (B)(6) 2022, PATIENT COMPLAINED ABOUT ¿SWELLING AND HOW HER EYE IS LOOKING DURING THIS STAGE IN HER HEALING.¿ ON (B)(6) 2022, PATIENT IS CONCERNED FOR HER SCAR TISSUE, AND SHE FEELS LIKE HER EYES ARE VERY SENSITIVE TO LIGHT AND AIR - AS SHE GETS DRY EYES OFTEN.¿ ON (B)(6) 2022, PATIENT UNDERWENT SURGERY FOR A CHIEF COMPLAINT OF ECTROPION, INVOLVING THE LEFT INFERIOR EYELID. THE ECTROPION IS RECURRING AND ASSOCIATED WITH BLURRED VISION. THE ECTROPION IS SEVERE IN SEVERITY.¿ THE SURGEON CATEGORIZED THE EYE ISSUE AS ¿COSMETIC DISSATISFACTION, EYELIDS¿ PER DIAGNOSIS CODE Z41.1, A PROCEDURE FOR PURPOSES OTHER THAN REMEDYING A HEALTH STATE. ¿SCAR WAS REALIGNED ALONG NORMAL ANATOMIC BOUNDARIES¿ DURIN

  Patient problems: Deformity/ Disfigurement; Pain; Visual Disturbances

  MAUDE report 21742878 ↗
• InjuryOct 14, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT NASAL RECONSTRUCTIVE SURGERY. ONE SYNTHES, L-SHAPE AND ONE SYNTHES, STRAIGHT 0.5MM, MULTI-HOLE TITANIUM MINI PLATES WERE USED IN HER SURGERY. ONE OF THE MINI-PLATES WAS SCREW FIXATED TO THE RIGHT NASAL BONE WITH THE MINI-PLATE EXTENDING SUBCUTANEOUSLY TO THE RIGHT EXTERNAL NASAL VALVE/NOSTRIL, FOR SUPPORT OF THE RIGHT INTERNAL AND EXTERNAL VALVES. THE OTHER MINI-PLATE WAS SUTURE-SECURED TO THE CARTILAGINOUS DORSAL AND CAUDAL NASAL SEPTUM, SUBMUCOSALLY, FOR SUPPORT OF THE NASAL DORSUM AND TIP. THE PATIENT DID WELL POSTOPERATIVELY UNTIL APPROXIMATELY (B)(6) 2020, WHEN EXCESSIVE MOBILITY OF THE RIGHT SIDE MINI-PLATE AT THE SCREW FIXATION SITES ON THE RIGHT NASAL BONE WAS DISCOVERED. REVISION SURGERY WITH RE-FIXATION OF THE RIGHT SIDE MINI-PLATE TO THE NASAL BONE WAS PERFORMED ON (B)(6) 2021. THE PATIENT DID WELL WITH NORMAL, COMFORTABLE BREATHING UNTIL (B)(6) 2024, WHEN THE RIGHT SIDE NASAL OBSTRUCTION RECURRED DUE TO VALVE COLLAPSE. THE PATIENT SUBSEQUENTLY UNDERWENT DENTAL X-RAYS FOR A SEPARATE ISSUE THAT REVEALED MINI-PLATE DISCONTINUITIES. DETAILED X-RAYS OF THE NASAL BONES WERE OBTAINED ON (B)(6) 2024, SHOWING COMPLETE DIS

  Patient problems: Obstruction/Occlusion

  MAUDE report 20439830 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL OF CRANIOS REINFORCED FAST SET PUTTY, ONE (1)TITANIUM MATRIXNEURO RECONSTRUCTION MESH, ONE (1) 3MM TITANIUM MATRIX MIDFACE SCREW, ONE (1) 10MM TITANIUM MATRIX MIDFACE SCREW, AND ONE (1) 4MM TITANIUM MATRIX MIDFACE SCREW DUE TO C DIFFICILE INFECTION POSTOPERATIVELY. ORIGINAL DATE OF SURGERY WAS ON (B)(6) 2015. THE PATIENT WAS ON A CEPHALEXIN ANTIBIOTIC THERAPY DUE TO COMPLICATION KNOWN ON (B)(6) 2015. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WAS UNKNOWN. HIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE SCREW SELF-DRILLING 4MM. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9587535 ↗
• InjuryJan 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF HARDWARE DUE TO INFECTION THAT WAS KNOWN ON (B)(6) 2016. THE ORIGINAL DATE OF THE IMPLANT WAS ON (B)(6) 2016. BONE AND SOFT TISSUE WERE DEBRIDED AND BONE AND HARDWARE WAS REMOVED IN THE LEFT FRONTAL BONE. THE PATIENT HAS A SHEET OF TITANIUM MESH OVER THE CRANIAL DEFECT IN THE LEFT FRONTAL BONE AND HAS PERIODICALLY HAD BREAKDOWN AND HEALING AND BREAKDOWN AND HEALING OVER THIS AREA. IT WAS FELT THAT THEY NEEDED TO EXPLORE THE WOUND, REMOVE SOME OF THE HARDWARE, WASH IT OUT, AND CLOSE IT IN LAYERS AND TRY TO DETERMINE IF THIS WOULD DEFINITIVELY SOLVE THE PROBLEM. THIS REPORT IS FOR ONE (1) TI MATRIXMIDFACE SCREW SELF-DRILLING 4MM. THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Impaired Healing; No Code Available; Unspecified Infection

  MAUDE report 9587168 ↗
• InjuryJul 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT A REMOVAL OF SYNPOR SMOOTH TITANIUM REINFORCED FAN PLATE & TITANIUM MATRIXMIDFACE SCREW SELF-DRILLING DUE TO INFECTION. PATIENT WAS INITIALLY TREATED ON AN UNKNOWN DATE FOR AN ORBITAL FLOOR FRACTURE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A TITANIUM (TI) MATRIXMIDFACE SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8808283 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL PROCEDURE OF SYNPOR SMOOTH TITANIUM REINFORCED FAN PLATE & TITANIUM MATRIXMIDFACE SCREW SELF-DRILLING DUE TO INFECTION. ORIGINALLY THE PATIENT HAD AN ORBITAL FLOOR FRACTURE SURGERY ON (B)(6) 2019. IMPLANTS WERE REMOVED SUCCESSFULLY. PATIENT OUTCOME AFTER THE REMOVAL PROCEDURE IS UNKNOWN. THIS REPORT IS FOR UNKNOWN QUANTITY OF TI MATRIXMIDFACE SCREW SELF-DRILLING 4 MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8803640 ↗
• MalfunctionSep 17, 2018Material Deformation; Material Deformation

  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 (TI) 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. CONCOMITANT DEVICES: TI MATRIXMIDFACE SCREW SELF--DRILLING 4MM (PART: 04.503.224.01, LOT: UNKNOWN, QUANTITY 122); TI MATRIXMIDFACE SCREW SELF--DRILLING 4MM (PART: 04.503.224.01, LOT: H370752, QUANTITY 1); TI MATRIXMIDFACE SCREW SELF--DRILLING 4MM (PART: 04.503.224.01, LOT: H424278, QUANTITY 3); TI MATRIXMIDFACE SCREW SELF--DRILLING 4MM (PART: 04.503.224.01, LOT: H435226, QUANTITY 1); TI MATRIXMIDFACE SCREW SELF--DRILLING 4MM (PART: 04.503.224.01, LOT: H457167, QU

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7881237 ↗
• MalfunctionJan 15, 2018Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT PIECES OF THE HEAD OF A MATRIX MIDFACE SCREW WERE DISINTEGRATING DURING A ZYGOMATICOMAXILLARY COMPLEX FRACTURE (ZMC) REPAIR ON (B)(6) 2017. A RESIDENT SURGEON WAS IMPLANTING A 4 MM SCREW INTO THE ZYGOMATIC FRONTAL SUTURE WHEN THE HEAD BEGAN TO BREAK APART AND DISINTEGRATE. THE SCREW WAS REMOVED SUCCESSFULLY AND NO FRAGMENTS REMAINED. THERE WAS A REPORTED TEN (10) MINUTE DELAY TO REMOVE AND REPLACE THIS SCREW. ANOTHER SCREW WAS USED. THE FINAL CONSTRUCT WAS A MIDFACE PLATE AND SCREWS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: MATRIXMIDFACE ORBITAL RIM PLATE 12 HOLES 0.7 MM THICK (04.503.373, LOT NUMBER UNKNOWN, QUANTITY 1), SCREWDRIVER HANDLE WITH HEX COUPLING-MEDIUM (311.006, LOT NUMBER UNKNOWN, QUANTITY 1), MATRIXMIDFACE SCREWDRIVER BLADE HEX COUPLING SELF-RETAINING 96 MM 03.503.203, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TITANIUM MATRIXMIDFACE SCREW SELF-DRILLING 4 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7191889 ↗

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