MatrixNEURO 04.503.104.01Recalls & reported problems
Synthes GmbH · TI MATRIXNEURO SCREW SELF-DRILLING 4MM · Class 2 · Implant
All models of MatrixNEURO (25)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes MatrixNEURO titanium screw is used in skull surgery. Reports most often describe screws breaking during surgery, sometimes leaving a tip in the skull, and screws that fail to cut. The database holds 244 reports, including no deaths and 81 injuries, with 163 malfunctions. No recalls name this device, and reports rose over the last year (36) compared with the year before (22).
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 252
- Deaths reported
- 0
- Injuries reported
- 81
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 252 adverse event reports that list this exact device (DI 10887587018324), received between Dec 8, 2017 and Sep 11, 2026 — classified as 81 injuries, 171 malfunctions.
The most frequently reported specific device problem is “Break” (128 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.
Reports received per month
Most reported problems
Device problems
- Break128
- Adverse Event Without Identified Device or Use Problem77
- Failure to Cut35
- Material Twisted/Bent13
- Device-Device Incompatibility4
- Difficult to Advance4
- Entrapment of Device4
- Manufacturing, Packaging or Shipping Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions112
- Unspecified Infection75
- No Consequences Or Impact To Patient32
- Insufficient Information15
- No Known Impact Or Consequence To Patient14
- No Code Available13
- Not Applicable7
- Foreign Body In Patient3
Recent adverse event reports
The 25 most recent of 252 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Break
Matrix neuro 4mm screws (04.503.104.01) broke during the procedure. 4 of the screws broke and the heads sheared off.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732817 ↗MalfunctionSep 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732810 ↗MalfunctionSep 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732806 ↗MalfunctionSep 11, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50732794 ↗MalfunctionSep 3, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50590548 ↗MalfunctionSep 3, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50590541 ↗MalfunctionSep 3, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50590515 ↗MalfunctionSep 3, 2026Break
It was reported that during the surgery, when insert the screw, the screw was broken, all the pieces were removed from the patient. Changed another three to continue the surgery, the same problem happened again. Total involved four screws. Another device was used to complete the surgery. There were no adverse consequences to the patient. No additional information could be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50590494 ↗MalfunctionJun 9, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW WAS BROKEN, THE TIP OF THE SCREW WAS LEFT IN THE SKULL. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443790 ↗MalfunctionJun 1, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25349272 ↗MalfunctionMay 18, 2026Break
IT WAS REPORTED THAT SURGEON WENT TO PUT IN A SCREW AND THE SCREW BROKE AS HE COMPLETED HIS LAST TWO TURNS. 4MM SCREW WAS USED. THERE WAS NO SURGICAL DELAY DUE TO THE REPORTED EVENT AND PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25200510 ↗MalfunctionMay 7, 2026Break
IT WAS REPORTED ON (B)(6) 2026 THAT SOME SCREWS BROKE IN A CASE. THREE OF THE SCREWS BROKE DURING THE IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111360 ↗MalfunctionMay 7, 2026Break
IT WAS REPORTED ON (B)(6) 2026 THAT SOME SCREWS BROKE IN A CASE. THREE OF THE SCREWS BROKE DURING THE IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111346 ↗MalfunctionMay 7, 2026Break
IT WAS REPORTED ON (B)(6) 2026, THAT SOME SCREWS BROKE IN A CASE. THREE OF THE SCREWS BROKE DURING THE IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25111345 ↗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 24820470 ↗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 24820434 ↗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 24820419 ↗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 24820388 ↗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 24820365 ↗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 24820342 ↗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 24820259 ↗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 24820136 ↗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 24820127 ↗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 24820117 ↗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 24820109 ↗
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 · TerminatedMatrixNEURO 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
Other PLATE, BONE devices
- RapidSorb 806.004.02SSynthes GmbH · PLATE, BONE146 reports
- TruMatch SD980.001Materialise NV · Plate, Bone1 recall21 reports
- Matrix 04.511.225.01Synthes GmbH · PLATE, BONE62 reports
- NA 400.834Synthes GmbH · PLATE, BONE58 reports
- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
- ProPlan CMF SD900.101Materialise NV · Plate, Bone1 recall1 report
- TruMatch SD980.013Materialise NV · Plate, Bone1 recall0 reports
- 2.4MM SYSTEM 91-2710Biomet Microfixation, Inc · Plate, Bone37 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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