MatrixNEURO 03.503.016Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10887587011547), received between Feb 2, 2017 and Mar 26, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (12 reports).

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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. THERE WAS NO REPORTED PATIENT OR USER HARM WITH NO DELAY IN SURGERY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699275 ↗
• MalfunctionMar 6, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A CRANIOTOMY THE HEADS OF THE SCREWS IN QUESTION STRIPPED WHILE BEING INSERTED WITH THE SHORT SCREWDRIVER BLADES. THE SCREWDRIVER BLADES WERE SWITCHED TO THE LONGER BLADES AND THE SCREWS WERE ABLE TO BE INSERTED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18849829 ↗
• MalfunctionMar 6, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON 16-FEBRUARY-2024, DURING A CRANIOTOMY THE HEADS OF THE SCREWS IN QUESTION STRIPPED WHILE BEING INSERTED WITH THE SHORT SCREWDRIVER BLADES. THE SCREWDRIVER BLADES WERE SWITCHED TO THE LONGER BLADES AND THE SCREWS WERE ABLE TO BE INSERTED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18849821 ↗
• MalfunctionOct 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MATRIXNEURO SCREWDRIVER BLADES WERE NOT HOLDING AN UNKNOWN SCREWS PROPERLY ON A ROUTINE CHECK. THERE WAS NO PATIENT NOR PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10701564 ↗
• MalfunctionOct 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MATRIXNEURO SCREWDRIVER BLADES WERE NOT HOLDING AN UNKNOWN SCREWS PROPERLY ON A ROUTINE CHECK. THERE WAS NO PATIENT NOR PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10701560 ↗
• MalfunctionOct 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MATRIXNEURO SCREWDRIVER BLADES WERE NOT HOLDING AN UNKNOWN SCREWS PROPERLY ON A ROUTINE CHECK. THERE WAS NO PATIENT NOR PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS FOR (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10701553 ↗
• MalfunctionOct 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MATRIXNEURO SCREWDRIVER BLADES WERE NOT HOLDING AN UNKNOWN SCREWS PROPERLY ON A ROUTINE CHECK. THERE WAS NO PATIENT NOR PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES 9 DEVICES. THIS REPORT IS FOR (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10701528 ↗
• MalfunctionOct 19, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE MATRIXNEURO SCREWDRIVER BLADES WERE NOT HOLDING AN UNKNOWN SCREWS PROPERLY ON A ROUTINE CHECK. THERE WAS NO PATIENT NOR PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES 9 DEVICES. THIS REPORT IS FOR (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT. THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10701515 ↗
• MalfunctionSep 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2020, DURING A CRANIOTOMY PROCEDURE, THE SCREWDRIVER BLADES FOR MATRIXNEURO BECAME WORN. IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT (PART# 03.503.016, LOT# UNKNOWN, QUANTITY# 9). THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT THIS IS REPORT 9 OF 10 FOR (B)(4). THIS COMPLAINT CAPTURES 10 OUT OF 20 DEVICES REPORTED. (B)(4) CAPTURES THE OTHER 10 DEVICES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507059 ↗
• MalfunctionSep 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2020, DURING A CRANIOTOMY PROCEDURE, THE SCREWDRIVER BLADES FOR MATRIXNEURO BECAME WORN. IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT (PART# 03.503.016, LOT# UNKNOWN, QUANTITY# 9). THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT THIS IS REPORT 10 OF 10 FOR (B)(4). THIS COMPLAINT CAPTURES 10 OUT OF 20 DEVICES REPORTED. (B)(4) CAPTURES THE OTHER 10 DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507058 ↗
• MalfunctionSep 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2020, DURING A CRANIOTOMY PROCEDURE, THE SCREWDRIVER BLADES FOR MATRIXNEURO BECAME WORN. IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT (PART# 03.503.016, LOT# UNKNOWN, QUANTITY# 9) THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT THIS IS REPORT 8 OF 10 FOR (B)(4). THIS COMPLAINT CAPTURES 10 OUT OF 20 DEVICES REPORTED. (B)(4) CAPTURES THE OTHER 10 DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507054 ↗
• MalfunctionSep 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2020, DURING A CRANIOTOMY PROCEDURE, THE SCREWDRIVER BLADES FOR MATRIXNEURO BECAME WORN. IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT (PART# 03.503.016, LOT# UNKNOWN, QUANTITY# 9) THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT THIS IS REPORT 7 OF 10 FOR (B)(4) THIS COMPLAINT CAPTURES 10 OUT OF 20 DEVICES REPORTED. (B)(4) CAPTURES THE OTHER 10 DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507053 ↗
• MalfunctionSep 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2020, DURING A CRANIOTOMY PROCEDURE, THE SCREWDRIVER BLADES FOR MATRIXNEURO BECAME WORN. IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT (PART# 03.503.016, LOT# UNKNOWN, QUANTITY# 9). THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT THIS IS REPORT 6 OF 10 FOR (B)(4). THIS COMPLAINT CAPTURES 10 OUT OF 20 DEVICES REPORTED. (B)(4) CAPTURES THE OTHER 10 DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507048 ↗
• MalfunctionSep 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2020, DURING A CRANIOTOMY PROCEDURE, THE SCREWDRIVER BLADES FOR MATRIXNEURO BECAME WORN. IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT (PART# 03.503.016, LOT# UNKNOWN, QUANTITY# 9) THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT THIS IS REPORT 5 OF 10 FOR (B)(4). THIS COMPLAINT CAPTURES 10 OUT OF 20 DEVICES REPORTED. (B)(4) CAPTURES THE OTHER 10 DEVICES

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507047 ↗
• MalfunctionSep 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2020, DURING A CRANIOTOMY PROCEDURE, THE SCREWDRIVER BLADES FOR MATRIXNEURO BECAME WORN. IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT (PART# 03.503.016, LOT# UNKNOWN, QUANTITY# 9). THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT. THIS IS REPORT 4 OF 10 FOR (B)(4). THIS COMPLAINT CAPTURES 10 OUT OF 20 DEVICES REPORTED. (B)(4) CAPTURES THE OTHER 10 DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507046 ↗
• MalfunctionSep 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2020, DURING A CRANIOTOMY PROCEDURE, THE SCREWDRIVER BLADES FOR MATRIXNEURO BECAME WORN. IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/ SHORT (PART# 03.503.016, LOT# UNKNOWN, QUANTITY# 9). THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT. THIS IS REPORT 3 OF 10 FOR (B)(4). THIS COMPLAINT CAPTURES 10 OUT OF 20 DEVICES REPORTED. (B)(4) CAPTURES THE OTHER 10 DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507044 ↗
• MalfunctionSep 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN AUGUST 2020, DURING A CRANIOTOMY PROCEDURE, THE SCREWDRIVER BLADES FOR MATRIXNEURO BECAME WORN. IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT (PART# 03.503.016, LOT# UNKNOWN, QUANTITY# 9). THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/SELF-RETAIN/SHORT THIS IS REPORT 2 OF 10 FOR (B)(4). THIS COMPLAINT CAPTURES 10 OUT OF 20 DEVICES REPORTED. (B)(4) CAPTURES THE OTHER 10 DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507042 ↗
• MalfunctionSep 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2020, DURING A CRANIOTOMY PROCEDURE, THE SCREWDRIVER BLADES FOR MATRIXNEURO BECAME WORN. IT IS UNKNOWN IF THERE WAS A DELAY IN SURGERY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/ SELF-RETAIN/ SHORT (PART # 03.503.016, LOT # UNKNOWN, QUANTITY# 9). THIS REPORT IS FOR ONE (1) MATRIXNEURO SCREWDRIVER BLADE HEX COUPLING/ SELF-RETAIN/ SHORT THIS IS REPORT 1 OF 10 FOR (B)(4). THIS COMPLAINT CAPTURES 10 OUT OF 20 DEVICES REPORTED. (B)(4) CAPTURES THE OTHER 10 DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10507039 ↗
• MalfunctionFeb 3, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED DURING AN UNKNOWN CRANIOTOMY PROCEDURE ON (B)(6) 2016, THE SELF-RETAINING MATRIX NEURO SCREWDRIVERS WOULD NOT RETAIN THE SCREWS PROPERLY. IT WAS REPORTED TWO (2) SETS WERE OPENED AND ALL EIGHT (8) SCREWDRIVERS PRESENTED WITH THE SAME ISSUE. SURGEON HAD THE SCREWDRIVER BLADES PUT IN BONE WAX, WHICH HELPED TO THEN RETAIN THE SCREWS. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. CONCOMITANT DEVICES REPORTED: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6299717 ↗
• MalfunctionFeb 3, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED DURING AN UNKNOWN CRANIOTOMY PROCEDURE ON (B)(6) 2016, THE SELF-RETAINING MATRIX NEURO SCREWDRIVERS WOULD NOT RETAIN THE SCREWS PROPERLY. IT WAS REPORTED TWO (2) SETS WERE OPENED AND ALL EIGHT (8) SCREWDRIVERS PRESENTED WITH THE SAME ISSUE. SURGEON HAD THE SCREWDRIVER BLADES PUT IN BONE WAX, WHICH HELPED TO THEN RETAIN THE SCREWS. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. CONCOMITANT DEVICES REPORTED: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6299706 ↗
• MalfunctionFeb 3, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED DURING AN UNKNOWN CRANIOTOMY PROCEDURE ON (B)(6) 2016, THE SELF-RETAINING MATRIXNEURO SCREWDRIVERS WOULD NOT RETAIN THE SCREWS PROPERLY. IT WAS REPORTED TWO (2) SETS WERE OPENED AND ALL EIGHT (8) SCREWDRIVERS PRESENTED WITH THE SAME ISSUE. SURGEON HAD THE SCREWDRIVER BLADES PUT IN BONE WAX, WHICH HELPED TO THEN RETAIN THE SCREWS. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. CONCOMITANT DEVICES REPORTED: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6299704 ↗
• MalfunctionFeb 2, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  IT WAS REPORTED DURING AN UNKNOWN CRANIOTOMY PROCEDURE ON (B)(6) 2016, THE SELF-RETAINING MATRIXNEURO SCREWDRIVERS WOULD NOT RETAIN THE SCREWS PROPERLY. IT WAS REPORTED TWO (2) SETS WERE OPENED AND ALL EIGHT (8) SCREWDRIVERS PRESENTED WITH THE SAME ISSUE. SURGEON HAD THE SCREWDRIVER BLADES PUT IN BONE WAX, WHICH HELPED TO THEN RETAIN THE SCREWS. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. CONCOMITANT DEVICES REPORTED: SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6296828 ↗