MatrixMANDIBLERecalls & reported problems across all models
Synthes GmbH · 79 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 392
- Deaths reported
- 0
- Injuries reported
- 71
- Recalls
- 0
We found 79 models of MatrixMANDIBLE by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 392 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2016 and Sep 16, 2026 — classified as 71 injuries, 321 malfunctions.
The most frequently reported specific device problem is “Break” (178 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 MatrixMANDIBLE problems
Device problems
- Break178
- Device-Device Incompatibility96
- Material Twisted/Bent61
- Adverse Event Without Identified Device or Use Problem22
- Material Deformation19
- Migration18
- Entrapment of Device15
- Failure to Cut15
Patient problems
- No Clinical Signs, Symptoms or Conditions241
- Insufficient Information31
- No Consequences Or Impact To Patient25
- No Patient Involvement23
- Unspecified Infection20
- Foreign Body In Patient15
- Swelling/ Edema13
- Failure of Implant12
MatrixMANDIBLE models
79 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MatrixMANDIBLE 03.503.071SCREWDRIVER65 reports
- MatrixMANDIBLE 03.503.072SCREWDRIVER44 reports
- MatrixMANDIBLE 03.503.057INSTRUMENT, CUTTING, ORTHOPEDIC33 reports
- MatrixMANDIBLE 03.503.476DRILL, BONE, POWERED26 reports
- MatrixMANDIBLE 03.503.047Guide, surgical, instrument20 reports
- MatrixMANDIBLE 04.503.556.01PLATE, BONE15 reports
- MatrixMANDIBLE 03.503.036GAUGE, DEPTH12 reports
- MatrixMANDIBLE 03.503.479DRILL, BONE, POWERED11 reports
- MatrixMANDIBLE 03.503.070SCREWDRIVER7 reports
- MatrixMANDIBLE 03.503.408DRILL, BONE, POWERED7 reports
- MatrixMANDIBLE 04.503.606.01PLATE, BONE7 reports
- MatrixMANDIBLE 03.503.451DRILL, BONE, POWERED6 reports
- MatrixMANDIBLE 03.503.561DRILL, BONE, POWERED6 reports
- MatrixMANDIBLE 04.503.405.01PLATE, BONE6 reports
- MatrixMANDIBLE 04.503.408.01PLATE, BONE6 reports
- MatrixMANDIBLE 04.503.444.01PLATE, BONE6 reports
- MatrixMANDIBLE 04.503.446.01PLATE, BONE6 reports
- MatrixMANDIBLE 04.503.640.01PLATE, BONE6 reports
- MatrixMANDIBLE 04.503.440.01PLATE, BONE5 reports
- MatrixMANDIBLE 04.503.642.01PLATE, BONE5 reports
- MatrixMANDIBLE 03.503.079INSTRUMENT, BENDING OR CONTOURING4 reports
- MatrixMANDIBLE 03.505.075DRIVER, WIRE, AND BONE DRILL, MANUAL4 reports
- MatrixMANDIBLE 04.503.435.01PLATE, BONE4 reports
- MatrixMANDIBLE 03.503.056PLIERS, SURGICAL3 reports
- MatrixMANDIBLE 03.503.073SCREWDRIVER3 reports
- MatrixMANDIBLE 03.503.081SCREWDRIVER3 reports
- MatrixMANDIBLE 03.503.168TEMPLATE3 reports
- MatrixMANDIBLE 03.503.461DRILL, BONE, POWERED3 reports
- MatrixMANDIBLE 03.503.471DRILL, BONE, POWERED3 reports
- MatrixMANDIBLE 04.503.506.01PLATE, BONE3 reports
- MatrixMANDIBLE 03.503.045Guide, surgical, instrument2 reports
- MatrixMANDIBLE 03.503.066SCREWDRIVER2 reports
- MatrixMANDIBLE 03.503.412DRILL, BONE, POWERED2 reports
- MatrixMANDIBLE 03.503.477DRILL, BONE, POWERED2 reports
- MatrixMANDIBLE 03.503.911TEMPLATE2 reports
- MatrixMANDIBLE 04.503.406.01PLATE, BONE2 reports
- MatrixMANDIBLE 04.503.414.01PLATE, BONE2 reports
- MatrixMANDIBLE 04.503.612.01PLATE, BONE2 reports
- MatrixMANDIBLE 04.503.706PLATE, BONE2 reports
- MatrixMANDIBLE 04.503.740PLATE, BONE2 reports
- MatrixMANDIBLE 04.503.742PLATE, BONE2 reports
- MatrixMANDIBLE SD449.503BPLATE, BONE1 report
- MatrixMANDIBLE SD449.510BPLATE, BONE1 report
- MatrixMANDIBLE SD449.511BPLATE, BONE1 report
- MatrixMANDIBLE SD449.513BPLATE, BONE1 report
- MatrixMANDIBLE 03.503.041INSTRUMENT, BENDING OR CONTOURING1 report
- MatrixMANDIBLE 03.503.058Guide, surgical, instrument1 report
- MatrixMANDIBLE 03.503.173TEMPLATE1 report
- MatrixMANDIBLE 03.503.174TEMPLATE1 report
- MatrixMANDIBLE 03.503.181TEMPLATE1 report
- MatrixMANDIBLE 03.503.184TEMPLATE1 report
- MatrixMANDIBLE 03.503.512DRILL, BONE, POWERED1 report
- MatrixMANDIBLE 03.503.910TEMPLATE1 report
- MatrixMANDIBLE 03.505.076DRIVER, WIRE, AND BONE DRILL, MANUAL1 report
- MatrixMANDIBLE 04.503.410.01PLATE, BONE1 report
- MatrixMANDIBLE 04.503.412.01PLATE, BONE1 report
- MatrixMANDIBLE 04.503.442.01PLATE, BONE1 report
- MatrixMANDIBLE 04.503.605.01PLATE, BONE1 report
- MatrixMANDIBLE 04.503.608.01PLATE, BONE1 report
- MatrixMANDIBLE 04.503.616.01PLATE, BONE1 report
- MatrixMANDIBLE 04.503.638.01PLATE, BONE1 report
- MatrixMANDIBLE 04.503.702PLATE, BONE1 report
- MatrixMANDIBLE 04.503.703PLATE, BONE1 report
- MatrixMANDIBLE 04.503.705PLATE, BONE1 report
- MatrixMANDIBLE 04.503.710PLATE, BONE1 report
- MatrixMANDIBLE 04.503.711PLATE, BONE1 report
- MatrixMANDIBLE 04.503.721PLATE, BONE1 report
- MatrixMANDIBLE 04.503.728PLATE, BONE1 report
- MatrixMANDIBLE 04.503.733PLATE, BONE1 report
- MatrixMANDIBLE 04.503.738PLATE, BONE1 report
- MatrixMANDIBLE 04.503.739PLATE, BONE1 report
- MatrixMANDIBLE 04.503.741PLATE, BONE1 report
- MatrixMANDIBLE 04.503.752PLATE, BONE1 report
- MatrixMANDIBLE 04.503.772PLATE, BONE1 report
- MatrixMANDIBLE 04.503.773PLATE, BONE1 report
- MatrixMANDIBLE 04.503.831PLATE, BONE1 report
- MatrixMANDIBLE 04.503.834PLATE, BONE1 report
- MatrixMANDIBLE 04.503.902PLATE, BONE1 report
- MatrixMANDIBLE 04.503.440.20PLATE, BONE1 report
Recent MatrixMANDIBLE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Device-Device Incompatibility
It was reported that the drill guide doesn't screw properly in the plate. There was no patient harm or surgical delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50785940 ↗MalfunctionJun 9, 2026Break
IT WAS REPORTED THAT THE MATRIX ORTHOGNATIC DEPTH GAUGE WAS BROKEN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25445427 ↗MalfunctionMay 11, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERTING THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. 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 25143372 ↗MalfunctionMay 11, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERTING THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. 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 25143342 ↗MalfunctionMay 11, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERTING THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. 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 25143317 ↗MalfunctionMay 11, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERTING THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. 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 25143284 ↗MalfunctionMay 11, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERTING THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. 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 25143180 ↗MalfunctionMay 11, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERTING THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. 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 25143158 ↗MalfunctionMay 11, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERTING THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. 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 25143130 ↗MalfunctionApr 30, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW WAS BROKEN AND ALL THE PIECES WERE REMOVED FROM THE PATIENT. IT WAS CHANGED TO 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. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25048576 ↗MalfunctionApr 30, 2026Break
IT WAS REPORTED THAT DURING THE SURGERY, THE SCREW WAS BROKEN AND ALL THE PIECES WERE REMOVED FROM THE PATIENT. IT WAS CHANGED TO 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. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25048485 ↗MalfunctionMar 23, 2026Break; Entrapment of Device
IT WAS REPORTED THE SURGEONS WERE IN AN OPEN REPAIR OF PARASYMPHYSEAL FRACTURE CASE. THE DOCTOR HAD USED THE DRILL BIT AND THE TIP BROKE AND UNFORTUNATELY STUCK ON THE MANDIBLE OF THE PATIENT. THE DOCTORS MENTIONED THAT THEY WOULD HAVE TO CRACK OPEN THE MANDIBLE TO RETRIEVE THE DRILL BIT. THE DOCTORS DID DISCLOSURE TO PATIENT AND DID THE NECESSARY DOCUMENTATION OF THE 2.5CM DRILL BIT TIP STUCK ON THE MANDIBLE. PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FRAGMENT WAS LEFT IN SITU. SURGICAL DELAY WAS UNKNOWN
Patient problems: Foreign Body In Patient
MAUDE report 24665314 ↗MalfunctionMar 20, 2026Break
IT WAS REPORTED THAT ON (B)(6) 2025, THE PLATE CUTTER WAS BROKEN IN TWO PIECES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24651632 ↗MalfunctionDec 2, 2025Break; Break
IT WAS REPORTED ON (B)(6) 2025, THE SCREW BROKE OFF DURING IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693237 ↗MalfunctionOct 21, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT TWO (2) SCREWDRIVER BLADES ARE NOT HOLDING THE SCREWS ANYMORE. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23351252 ↗
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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