MatrixNEURO 04.503.103.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10887587018294), received between Feb 24, 2022 and Apr 8, 2026 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (8 reports).

1 other recall cover devices cleared under the same FDA submission (K042365, K123723); 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 18, 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.

• MalfunctionApr 8, 2026Failure to Cut

  IT WAS REPORTED THE SCREWS WERE NOTED TO BE DULL. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820318 ↗
• MalfunctionApr 8, 2026Failure to Cut

  IT WAS REPORTED THE SCREWS WERE NOTED TO BE DULL. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820306 ↗
• MalfunctionApr 8, 2026Failure to Cut

  IT WAS REPORTED THE SCREWS WERE NOTED TO BE DULL. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820300 ↗
• InjuryFeb 24, 2022Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO SCREWS PULLING OUT. PATIENT HAD ORIGINALLY UNDERGONE A CRANIOTOMY WITH NINE 3MM MATRIX NEURO SCREWS AND FOUR 17MM BURR HOLE COVERS MATRIX NEURO. PATIENT CRANIOTOMY REVISED WITH NEW PLATES AND SCREWS AS THE FLAP CAME LOOSE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A TI MATRIXNEURO SCREW SELF-DRILLING 3MM. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13593725 ↗
• InjuryFeb 24, 2022Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO SCREWS PULLING OUT. PATIENT HAD ORIGINALLY UNDERGONE A CRANIOTOMY WITH NINE 3MM MATRIX NEURO SCREWS AND FOUR 17MM BURR HOLE COVERS MATRIX NEURO. PATIENT CRANIOTOMY REVISED WITH NEW PLATES AND SCREWS AS THE FLAP CAME LOOSE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A TI MATRIXNEURO SCREW SELF-DRILLING 3MM. THIS IS REPORT 8 OF 9 FOR PC: (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13593613 ↗
• InjuryFeb 24, 2022Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO SCREWS PULLING OUT. PATIENT HAD ORIGINALLY UNDERGONE A CRANIOTOMY WITH NINE 3MM MATRIX NEURO SCREWS AND FOUR 17MM BURR HOLE COVERS MATRIX NEURO. PATIENT CRANIOTOMY REVISED WITH NEW PLATES AND SCREWS AS THE FLAP CAME LOOSE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A TI MATRIXNEURO SCREW SELF-DRILLING 3MM. THIS IS REPORT 7 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13593007 ↗
• InjuryFeb 24, 2022Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO SCREWS PULLING OUT. PATIENT HAD ORIGINALLY UNDERGONE A CRANIOTOMY WITH NINE 3MM MATRIX NEURO SCREWS AND FOUR 17MM BURR HOLE COVERS MATRIX NEURO. PATIENT CRANIOTOMY REVISED WITH NEW PLATES AND SCREWS AS THE FLAP CAME LOOSE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A TI MATRIXNEURO SCREW SELF-DRILLING 3MM. THIS IS REPORT 6 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13592981 ↗
• InjuryFeb 24, 2022Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO SCREWS PULLING OUT. PATIENT HAD ORIGINALLY UNDERGONE A CRANIOTOMY WITH NINE 3MM MATRIX NEURO SCREWS AND FOUR 17MM BURR HOLE COVERS MATRIX NEURO. PATIENT CRANIOTOMY REVISED WITH NEW PLATES AND SCREWS AS THE FLAP CAME LOOSE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A TI MATRIXNEURO SCREW SELF-DRILLING 3MM. THIS IS REPORT 5 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13592953 ↗
• InjuryFeb 24, 2022Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO SCREWS PULLING OUT. PATIENT HAD ORIGINALLY UNDERGONE A CRANIOTOMY WITH NINE 3MM MATRIX NEURO SCREWS AND FOUR 17MM BURR HOLE COVERS MATRIX NEURO. PATIENT CRANIOTOMY REVISED WITH NEW PLATES AND SCREWS AS THE FLAP CAME LOOSE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A TI MATRIXNEURO SCREW SELF-DRILLING 3MM. THIS IS REPORT 4 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13592944 ↗
• InjuryFeb 24, 2022Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO SCREWS PULLING OUT. PATIENT HAD ORIGINALLY UNDERGONE A CRANIOTOMY WITH NINE 3MM MATRIX NEURO SCREWS AND FOUR 17MM BURR HOLE COVERS MATRIX NEURO. PATIENT CRANIOTOMY REVISED WITH NEW PLATES AND SCREWS AS THE FLAP CAME LOOSE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A TI MATRIXNEURO SCREW SELF-DRILLING 3MM. THIS IS REPORT 3 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13592933 ↗
• InjuryFeb 24, 2022Migration; Migration

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022, DUE TO SCREWS PULLING OUT. PATIENT HAD ORIGINALLY UNDERGONE A CRANIOTOMY WITH NINE 3MM MATRIX NEURO SCREWS AND FOUR 17MM BURR HOLE COVERS MATRIX NEURO. PATIENT CRANIOTOMY REVISED WITH NEW PLATES AND SCREWS AS THE FLAP CAME LOOSE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A TI MATRIXNEURO SCREW SELF-DRILLING 3MM. THIS IS REPORT 2 OF 9 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13592904 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042365, K123723. One submission often covers many models, so check the product and lot details in each record.

• Z-2698-2020 · Jun 18, 2020 · Terminated
  MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedur