MatrixRecalls & reported problems across all models
Synthes GmbH · 80 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 597
- Deaths reported
- 0
- Injuries reported
- 142
- Recalls
- 0
We found 80 models of Matrix by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 597 adverse event reports in the FDA's MAUDE database, received between Oct 14, 2013 and Sep 29, 2026 — classified as 142 injuries, 455 malfunctions.
The most frequently reported specific device problem is “Break” (147 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 Matrix problems
Device problems
- Break147
- Material Integrity Problem132
- Adverse Event Without Identified Device or Use Problem51
- Dull, Blunt50
- Material Twisted/Bent45
- Compatibility Problem35
- Device-Device Incompatibility23
- Device Slipped21
Patient problems
- No Clinical Signs, Symptoms or Conditions190
- No Consequences Or Impact To Patient125
- No Known Impact Or Consequence To Patient76
- No Patient Involvement62
- Nonunion/Delayed-union Bone Fracture62
- No Code Available37
- Failure of Implant19
- Insufficient Information16
Matrix models
80 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Matrix 03.632.036ORTHOPEDIC MANUAL SURGICAL INSTRUMENT90 reports
- Matrix 03.632.072SCREWDRIVER83 reports
- Matrix 04.511.225.01PLATE, BONE62 reports
- Matrix 03.632.002SCREWDRIVER56 reports
- Matrix 03.632.074SCREWDRIVER28 reports
- Matrix 03.632.001ORTHOPEDIC MANUAL SURGICAL INSTRUMENT27 reports
- Matrix 04.511.205.01PLATE, BONE18 reports
- Matrix 03.632.037ORTHOPEDIC MANUAL SURGICAL INSTRUMENT16 reports
- Matrix 03.632.005SCREWDRIVER15 reports
- Matrix 03.632.073SCREWDRIVER12 reports
- Matrix 04.632.001Orthosis, spondylolisthesis spinal fixation12 reports
- Matrix 03.632.004SCREWDRIVER11 reports
- Matrix 04.511.206.01PLATE, BONE11 reports
- Matrix 03.632.003SCREWDRIVER10 reports
- Matrix 03.511.248DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE10 reports
- Matrix 03.632.075SCREWDRIVER6 reports
- Matrix 03.632.083ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- Matrix 03.511.246DRILL, BONE, POWERED6 reports
- Matrix 04.511.325PLATE, BONE6 reports
- Matrix 04.632.000Orthosis, spondylolisthesis spinal fixation5 reports
- Matrix 04.632.645APPLIANCE, FIXATION, SPINAL INTERLAMINAL5 reports
- Matrix 03.632.085ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- Matrix 03.632.087ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- Matrix 04.632.750APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- Matrix 04.639.645APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- Matrix 04.639.650APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY4 reports
- Matrix 04.606.650APPLIANCE, FIXATION, SPINAL INTERLAMINAL3 reports
- Matrix 04.632.640Orthosis, spondylolisthesis spinal fixation3 reports
- Matrix 03.511.003FORCEPS3 reports
- Matrix 03.511.252DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)3 reports
- Matrix 04.511.204.01PLATE, BONE3 reports
- Matrix 04.511.307PLATE, BONE3 reports
- Matrix 03.632.009ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 reports
- Matrix 04.606.740APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- Matrix 04.632.880APPLIANCE, FIXATION, SPINAL INTERLAMINAL2 reports
- Matrix 04.634.002Orthosis, spinal pedicle fixation, for degenerative disc disease2 reports
- Matrix 04.639.745APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
- Matrix 09.632.099ORTHOSIS, SPINAL PEDICLE FIXATION2 reports
- Matrix 03.632.123CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY2 reports
- Matrix 03.503.248DRILL, BONE, POWERED2 reports
- Matrix 03.503.264DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)2 reports
- Matrix 03.511.340DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)2 reports
- Matrix 04.511.234.01PLATE, BONE2 reports
- Matrix 04.511.305PLATE, BONE2 reports
- Matrix 04.511.324PLATE, BONE2 reports
- Matrix 04.511.385PLATE, BONE2 reports
- Matrix 04.511.401PLATE, BONE2 reports
- Matrix 04.511.421PLATE, BONE2 reports
- Matrix 03.632.007ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Matrix 03.632.010ORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- Matrix 04.632.740APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Matrix 04.632.745ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Matrix 04.632.840Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- Matrix 04.632.860ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Matrix 04.632.955APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Matrix 04.632.990APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Matrix 04.633.215APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 report
- Matrix 04.639.635APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Matrix 04.639.750ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Matrix 04.639.860Orthosis, spinal pedicle fixation, for degenerative disc disease1 report
- Matrix 04.639.880ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Matrix 04.639.965APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 report
- Matrix 04.639.970ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Matrix 04.639.999ORTHOSIS, SPINAL PEDICLE FIXATION1 report
- Matrix 03.503.244DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)1 report
- Matrix 03.511.310DRILL, BONE, POWERED1 report
- Matrix 03.511.343DRILL, BONE, POWERED1 report
- Matrix 04.511.224.01PLATE, BONE1 report
- Matrix 04.511.226.01PLATE, BONE1 report
- Matrix 04.511.235.01PLATE, BONE1 report
- Matrix 04.511.304PLATE, BONE1 report
- Matrix 04.511.341PLATE, BONE1 report
- Matrix 04.511.384PLATE, BONE1 report
- Matrix 04.511.388PLATE, BONE1 report
- Matrix 04.511.402PLATE, BONE1 report
- Matrix 04.511.404PLATE, BONE1 report
- Matrix 04.511.422PLATE, BONE1 report
- Matrix 04.511.423PLATE, BONE1 report
- Matrix 04.511.424PLATE, BONE1 report
- Matrix 04.511.461PLATE, BONE1 report
Recent Matrix adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Manufacturing, Packaging or Shipping Problem
It was reported that the customer received an empty screw package. The package was discarded. There was no reported patient or user harm. There was no significant delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933158 ↗MalfunctionSep 21, 2026Material Integrity Problem
It was reported that there was a broken driver. There was no patient harm or surgical delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842401 ↗InjuryJun 18, 2026Device Slipped
IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT UNDERWENT A PROCEDURE, IMPLANTING PLATES AND SCREWS IN THE MANDIBLE AND MAXILLA. ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO PAIN, SWELLING AND DIAGNOSED WITH INFECTION. ON (B)(6) 2022 THE PATIENT UNDERWENT AN I&D PROCEDURE. DURING THAT PROCEDURE, IT WAS DISCOVERED A SCREW WAS LOOSE IN THE RIGHT MANDIBLE. THE LOOSE SCREW WAS REMOVED. ADDITIONALLY, ONE PLATE AND THREE OTHER SCREWS WERE REMOVED, BUT THERE WAS NO SPECIFIC ALLEGATIONS AGAINST THOSE DEVICES. ALL OTHER IMPLANTS REMAINED.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 25548422 ↗MalfunctionMay 27, 2026Break; Entrapment of Device
IT WAS REPORTED DURING A LEFORT I PROCEDURE ON (B)(6) 2025, A DRILL BIT FRACTURED INTRAOPERATIVELY. THE BROKEN FRAGMENT COULD NOT BE LOCATED BY THE SURGICAL TEAM DURING THE PROCEDURE. AN X-RAY PERFORMED AT THE END OF THE CASE CONFIRMED THAT A PORTION OF THE DRILL BIT HAD BEEN RETAINED WITHIN THE PATIENT¿S FACIAL TISSUES.
Patient problems: Foreign Body In Patient
MAUDE report 25302997 ↗MalfunctionApr 30, 2026Material Integrity Problem
IT WAS REPORTED DURING A PROCEDURE DURING FINAL TIGHTENING THE ANTI TORQUE WAS NOT FULLY SEATED THEREFORE THE T25 DRIVER STRIPPED. ANOTHER DEVICE WAS USED. NO SURGICAL DELAY OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25048571 ↗MalfunctionApr 28, 2026Break
IT WAS REPORTED THAT HAND PIECE FOR BATTERY POWERED DRIVER AND PL-HOLDER F/MATRIX PLATES WERE BROKEN DURING INTRA-OPERATIVE USE. BOTH DEVICES WERE FOUND SEPARATED INTO TWO OR MORE PIECES. THERE WAS NO REPORTED PATIENT HARM OR SIGNIFICANT DELAY ASSOCIATED WITH THE EVENT, AND NO OBSERVABLE CLINICAL SYMPTOMS OR CONSEQUENCES TO THE PATIENT WERE IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25017393 ↗MalfunctionApr 3, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, THE PLATE WAS BROKEN OFF AFTER CONTOURING. 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 24780194 ↗MalfunctionFeb 12, 2026Break
ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY IN RELATION TO THE REPORTED EVENT? - NO. B. WAS OTHER MEDICAL INTERVENTION REQUIRED? - NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24324851 ↗MalfunctionJan 29, 2026Device-Device Incompatibility
IT WAS REPORTED DURING AN ORTHOGNATHIC PROCEDURE, AFTER DRILLING WITH DRILL, THE SCREW OVER INSERTED INTO THE PLATE AND PASSED THROUGH THE PLATE. THE SURGEON WANTED TO TRY A NEW PLATE AND REUSED THE SCREW AND IT HAPPENED AGAIN. USED DIFFERENT PLATES AND SCREWS AND IT WORKED AS EXPECTED. NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24211080 ↗MalfunctionJan 29, 2026Device-Device Incompatibility
IT WAS REPORTED DURING AN ORTHOGNATHIC PROCEDURE, AFTER DRILLING WITH DRILL, THE SCREW OVER INSERTED INTO THE PLATE AND PASSED THROUGH THE PLATE. THE SURGEON WANTED TO TRY A NEW PLATE AND RE USED THE SCREW AND IT HAPPENED AGAIN. USED DIFFERENT PLATES AND SCREWS AND IT WORKED AS EXPECTED. NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24210661 ↗MalfunctionJan 29, 2026Device-Device Incompatibility
IT WAS REPORTED DURING AN ORTHOGNATHIC PROCEDURE, AFTER DRILLING WITH DRILL, THE SCREW OVER INSERTED INTO THE PLATE AND PASSED THROUGH THE PLATE. THE SURGEON WANTED TO TRY A NEW PLATE AND RE USED THE SCREW AND IT HAPPENED AGAIN. USED DIFFERENT PLATES AND SCREWS AND IT WORKED AS EXPECTED. NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24210519 ↗MalfunctionJan 29, 2026Device-Device Incompatibility
IT WAS REPORTED DURING AN ORTHOGNATHIC PROCEDURE, AFTER DRILLING WITH DRILL, THE SCREW OVER INSERTED INTO THE PLATE AND PASSED THROUGH THE PLATE. THE SURGEON WANTED TO TRY A NEW PLATE AND RE USED THE SCREW AND IT HAPPENED AGAIN. USED DIFFERENT PLATES AND SCREWS AND IT WORKED AS EXPECTED. NO PATIENT HARM AND NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24210419 ↗MalfunctionJan 9, 2026Material Integrity Problem
IT WAS REPORTED ON (B)(6) 2025, THAT DURING POST OP INSPECTION, MULTIPLE MATRIX SCREWDRIVERS WERE FOUND TO HAVE DRIVER TIPS THAT WERE WORN, BUT NOT YET BROKEN OR STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24018733 ↗MalfunctionJan 9, 2026Material Integrity Problem
IT WAS REPORTED ON (B)(6) 2025 THAT DURING POST OP INSPECTION, MULTIPLE MATRIX SCREWDRIVERS WERE FOUND TO HAVE DRIVER TIPS THAT WERE WORN, BUT NOT YET BROKEN OR STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24018731 ↗MalfunctionJan 9, 2026Material Integrity Problem
IT WAS REPORTED ON (B)(6) 2025 THAT DURING POST OP INSPECTION, MULTIPLE MATRIX SCREWDRIVERS WERE FOUND TO HAVE DRIVER TIPS THAT WERE WORN, BUT NOT YET BROKEN OR STRIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24018729 ↗
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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