MatrixNEURO 04.503.105.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10887587018355), received between Oct 2, 2024 and Dec 22, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (11 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.

• MalfunctionDec 22, 2025Break; Entrapment of Device; Break; Entrapment of Device

  ADDITIONAL INFORMATION RECEIVED FROM SALES REP VIA PHONE TODAY STATES THAT AFTER INVESTIGATION, THE PATIENT UNDERWENT GLIOMA RESECTION IN THE HOSPITAL DUE TO "BRAIN GLIOMA" ON (B)(6) 2025. THE SURGEON USED 04.503.105.04S FOR SKULL FIXATION DURING THE SURGERY. THE SCREW WAS BROKEN DURING THE TIGHTENING. THE SURGEON REMOVED THE BROKEN SCREW HEAD. THE SCREW TIP FIXED IN THE SKULL WAS NOT REMOVED. THE SURGEON CONFIRMED THE STABILITY OF SKULL FIXATION AND REPLACED IT WITH A NEW PRODUCT TO CONTINUE THE SURGERY. DURING THIS PERIOD, THE SURGICAL TIME WAS EXTENDED BY ABOUT 30 MINUTES. THE EVENT DID NOT CAUSE ANY OTHER HARM TO THE PATIENT AND NO SUBSEQUENT ADVERSE EVENT REPORTS WERE RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23863312 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED TWO SCREWS BROKE DURING SURGERY. A THIRD SCREW WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732399 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED TWO SCREWS BROKE DURING SURGERY. A THIRD SCREW WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732392 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED THE SCREW BROKE DURING SURGERY. ANOTHER SCREW WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732324 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED TWO SCREWS BROKE DURING SURGERY. A THIRD SCREW WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23732123 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED TWO SCREWS BROKE DURING SURGERY. A THIRD SCREW WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23731982 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED TWO SCREWS BROKE DURING SURGERY. A THIRD SCREW WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23731752 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED TWO SCREWS BROKE DURING SURGERY. A THIRD SCREW WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23731743 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED TWO SCREWS BROKE DURING SURGERY. A THIRD SCREW WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23731394 ↗
• MalfunctionDec 5, 2025Break; Break

  IT WAS REPORTED TWO SCREWS BROKE DURING SURGERY. A THIRD SCREW WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23731317 ↗
• MalfunctionOct 2, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2024. THE SURGEON USED FOUR MATRIXNEURO SCREWS. THE LAST ONE'S SCREW HEAD BROKE OFF WHILE THE BODY OF THE SCREW REMAINED IN THE SKULL. THE SURGEON DRILLED OUT THE SCREW BODY AND WASHED AWAY WITH SALINE, THEN REMOVED ALL BUT ONE MATRIXNEURO SCREW IN CASE IT WAS A BATCH ISSUE. THE LAST MATRIXNEURO SCREW WAS LEFT ALONG BECAUSE IT WAS SOLIDLY IN THE BONE AND THE SURGEON DIDN'T WANT TO ACCIDENTALLY BREAK THE HEAD. SURGEON THEN OPTED FOR SELF-TAPPING MATRIXMIDFACE SCREWS WHICH WORKED WELL. PROCEDURE WAS COMPLETED WITH A FIFTEEN MINUTE DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A TI MATRIXNEURO SCREW SELF-DRILLING 5MM.

  Patient problems: Foreign Body In Patient

  MAUDE report 20351907 ↗

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