Matrix 04.511.206.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10887587023458), received between Aug 24, 2018 and Jun 18, 2026 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

1 other recall cover devices cleared under the same FDA submission (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2026Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT UNDERWENT A PROCEDURE, IMPLANTING PLATES AND SCREWS IN THE MANDIBLE AND MAXILLA. ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO PAIN, SWELLING AND DIAGNOSED WITH INFECTION. ON (B)(6) 2022 THE PATIENT UNDERWENT AN I&D PROCEDURE. DURING THAT PROCEDURE, IT WAS DISCOVERED A SCREW WAS LOOSE IN THE RIGHT MANDIBLE. THE LOOSE SCREW WAS REMOVED. ADDITIONALLY, ONE PLATE AND THREE OTHER SCREWS WERE REMOVED, BUT THERE WAS NO SPECIFIC ALLEGATIONS AGAINST THOSE DEVICES. ALL OTHER IMPLANTS REMAINED.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 25548422 ↗
• MalfunctionSep 9, 2024Break; Break

  A METAL STRIP WAS PEELED OFF WHEN A SCREW INSERTING ON A PLATE TO MAXILLA BONE. IT IS UNKNOWN IF IT CAME FROM THE PLATE OR THE SCREW. BOTH DEVICES WERE STILL IMPLANTED IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169239 ↗
• MalfunctionNov 9, 2023Material Twisted/Bent; Material Twisted/Bent

  THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: Insufficient Information

  MAUDE report 18102512 ↗
• MalfunctionNov 9, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM BRAZIL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 06-OCTOBER-2023, THE SCREWS IN QUESTION WERE HAVING TROUBLE ATTACHING TO THE SCREWDRIVER. DIFFERENT SCREWDRIVERS WERE USED IN AN ATTEMPT TO DETERMINE IF THE ISSUE WAS CAUSED BY THE SCREW OR SCREWDRIVER. IT WAS DETERMINED THAT THE SCREW HEADS WERE NOT MAGNETIZED AS USUAL. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. THE SCREWS WERE USED DURING THE PROCEDURE AS ORIGINALLY INTENDED, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18102508 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WILL UNDERGO REVISION SURGERY ON AN UNKNOWN DATE, DUE TO UNSTABLE FIXATION AND MALOCCLUSION. PATIENT ORIGINALLY UNDERWENT AN ORTHOGNATHIC PROCEDURE INVOLVING THE UPPER AND LOWER JAW ON (B0(6) 2023. IT HAS BEEN DETERMINED BY THE SURGEON AND ORTHODONTIST THAT THE MAXILLARY SURGERY IS STABLE, HOWEVER, THE MANDIBULAR PORTION IS NOT AND MUST BE REVISED. THIS REPORT IS FOR A 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM. THIS IS REPORT 5 OF 9 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17450994 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WILL UNDERGO REVISION SURGERY ON AN UNKNOWN DATE, DUE TO UNSTABLE FIXATION AND MALOCCLUSION. PATIENT ORIGINALLY UNDERWENT AN ORTHOGNATHIC PROCEDURE INVOLVING THE UPPER AND LOWER JAW ON (B)(6), 2023. IT HAS BEEN DETERMINED BY THE SURGEON AND ORTHODONTIST THAT THE MAXILLARY SURGERY IS STABLE, HOWEVER, THE MANDIBULAR PORTION IS NOT AND MUST BE REVISED. THIS REPORT IS FOR A 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM. THIS IS REPORT 4 OF 9 FOR (B)(4). ADDITIONAL REPORTS ARE CAPTURED UNDER (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17450954 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WILL UNDERGO REVISION SURGERY ON AN UNKNOWN DATE, DUE TO UNSTABLE FIXATION AND MALOCCLUSION. PATIENT ORIGINALLY UNDERWENT AN ORTHOGNATHIC PROCEDURE INVOLVING THE UPPER AND LOWER JAW ON (B)(6) 2023. IT HAS BEEN DETERMINED BY THE SURGEON AND ORTHODONTIST THAT THE MAXILLARY SURGERY IS STABLE, HOWEVER, THE MANDIBULAR PORTION IS NOT AND MUST BE REVISED. THIS REPORT IS FOR A 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM. THIS IS REPORT 3 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17450915 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WILL UNDERGO REVISION SURGERY ON AN UNKNOWN DATE, DUE TO UNSTABLE FIXATION AND MALOCCLUSION. PATIENT ORIGINALLY UNDERWENT AN ORTHOGNATHIC PROCEDURE INVOLVING THE UPPER AND LOWER JAW ON (B)(6) 2023. IT HAS BEEN DETERMINED BY THE SURGEON AND ORTHODONTIST THAT THE MAXILLARY SURGERY IS STABLE, HOWEVER, THE MANDIBULAR PORTION IS NOT AND MUST BE REVISED. THIS REPORT IS FOR A 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM. THIS IS REPORT 1 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17450753 ↗
• MalfunctionApr 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2022 DURING ORTHOGNATHIC SURGERY, DURING THE FIXATION OF MANDIBLE FOLLOWING A BILATERAL SAGITTAL SPLIT OSTEOTOMY PROCEDURE WHILE INSERTING THE SCREW INTO THE PLATE, IT PROTRUDED THROUGH THE INDICATED PLATE HOLE, WHILE ATTEMPTING TO SECURE THE PLATE TO THE BONE. THIS HAPPENED TO THE PLATE ON THE LEFT AND THE RIGHT SIDE OF MANDIBLE DURING FIXATION. PROCEDURE COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251774 ↗
• MalfunctionApr 26, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE WHEN TRYING TO IMPLANT THE PATIENT, THE MATRIX SCREW HEAD THAT WE ARE USING FELL/SLIPPED THROUGH THE HOLE IN THE PLATE. WE USED AN ALTERNATIVE FIXATING THE MANDIBLE. NO SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. NO PATIENT CONSEQUENCES. CONCOMITANT DEVICE REPORTED: UNK - PLATES: MATRIXORTHOGNATHIC (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14206829 ↗
• MalfunctionAug 24, 2018Failure to Advance; Failure to Cut; Difficult to Advance; Failure to Advance; Failure to Cut; Difficult to Advance

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2018, THE TITANIUM (TI) MATRIX SCREW SELF-TAPPING WOULD NOT ENGAGE INTO THE PRE-DRILLED HOLE. A MATRIX DRILL BIT J-LATCH WAS USED TO PUT IN THE SCREW. IT IS UNKNOWN IF IT WAS AN ISSUE WITH THE SCREW OR THE DRILL BIT. ANOTHER UNKNOWN DRILL BIT AND UNKNOWN SCREW WERE USED, AND THEY WORKED FINE. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY OR WHAT THE PATIENT OUTCOME WAS. THIS REPORT IS FOR A 1.85MM TI MATRIX SCREW SELF-TAPPING/6MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 7813511 ↗

Recalls under the same FDA submission

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

• 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