MatrixNEURORecalls & reported problems across all models
Synthes GmbH · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 422
- Deaths reported
- 0
- Injuries reported
- 125
- Recalls
- 0
We found 25 models of MatrixNEURO by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 422 adverse event reports in the FDA's MAUDE database, received between Dec 21, 2016 and Sep 11, 2026 — classified as 125 injuries, 297 malfunctions.
The most frequently reported specific device problem is “Break” (152 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MatrixNEURO problems
Device problems
- Break152
- Adverse Event Without Identified Device or Use Problem109
- Material Twisted/Bent77
- Device-Device Incompatibility48
- Failure to Cut38
- Failure To Adhere Or Bond11
- Migration8
- Entrapment of Device6
Patient problems
- No Clinical Signs, Symptoms or Conditions177
- Unspecified Infection101
- No Consequences Or Impact To Patient61
- Insufficient Information28
- No Known Impact Or Consequence To Patient23
- No Code Available19
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available8
- No Patient Involvement8
MatrixNEURO models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MatrixNEURO 04.503.104.01PLATE, BONE252 reports
- MatrixNEURO 03.503.017SCREWDRIVER79 reports
- MatrixNEURO 03.503.016SCREWDRIVER22 reports
- MatrixNEURO 04.503.103.01PLATE, BONE11 reports
- MatrixNEURO 04.503.105.01PLATE, BONE11 reports
- MatrixNEURO 04.503.061PLATE, BONE7 reports
- MatrixNEURO 04.503.062PLATE, BONE5 reports
- MatrixNEURO 04.503.104.20PLATE, BONE5 reports
- MatrixNEURO 04.503.064PLATE, BONE4 reports
- MatrixNEURO 04.503.073PLATE, BONE4 reports
- MatrixNEURO 04.503.072PLATE, BONE3 reports
- MatrixNEURO 04.503.121PLATE, BONE3 reports
- MatrixNEURO 04.503.069PLATE, BONE2 reports
- MatrixNEURO 04.503.097PLATE, BONE2 reports
- MatrixNEURO 04.503.122PLATE, BONE2 reports
- MatrixNEURO 04.502.022PLATE, BONE1 report
- MatrixNEURO 04.502.073PLATE, BONE1 report
- MatrixNEURO 04.503.029PLATE, BONE1 report
- MatrixNEURO 04.503.057PLATE, BONE1 report
- MatrixNEURO 04.503.063PLATE, BONE1 report
- MatrixNEURO 04.503.065PLATE, BONE1 report
- MatrixNEURO 04.503.068PLATE, BONE1 report
- MatrixNEURO 04.503.081PLATE, BONE1 report
- MatrixNEURO 04.503.083PLATE, BONE1 report
- MatrixNEURO 04.503.098PLATE, BONE1 report
Recent MatrixNEURO adverse event reports
The 15 most recent reports across all models, 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 21, 2026Nonstandard Device
IT WAS REPORTED THAT THE ONE OF THE SCREW HOLES OF THE TI MATRIXNEURO CONTOUR MESH MASTOID/MEDIUM/MALLEABLE IS SIDEWAYS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24944881 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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