MatrixMANDIBLE 03.505.076Recalls & reported problems
Synthes GmbH · Ø1.5MM DRILL BIT W/8MM STOP 15MM F/90° SCRWDRVR MTRXMANDBL · Class 2
All models of MatrixMANDIBLE (79)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587013626), received between Sep 19, 2022 and Sep 19, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Entrapment of Device” (1 report).
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 16, 2026.
Most reported problems
Device problems
- Entrapment of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2022Entrapment of Device; Entrapment of Device
DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A MANDIBULAR ORIF FOR TREATING MANDIBULAR FRACTURE ON (B)(6) 2022, THE SURGEON WAS FIXATING A PLATE AND THE DRILL BIT BROKE OFF. THE SURGEON DECIDED TO LEAVE A FRAGMENT INSIDE OF THE PATIENT SINCE THE PLATE HAD BEEN SECURED IN THE LESION WITH SCREWS. THE PROCEDURE WAS DELAYED BY LESS THAN 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A Ø1.5MM DRILL BIT W/8MM STOP 15MM F/90° SCRWDRVR MTRXMANDBL. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Foreign Body In Patient
MAUDE report 15446641 ↗
Other DRIVER, WIRE, AND BONE DRILL, MANUAL devices
- NA 03.505.003Synthes GmbH · DRIVER, WIRE, AND BONE DRILL, MANUAL154 reports
- NA 5400007000Stryker Corporation · DRIVER, WIRE, AND BONE DRILL, MANUAL20 reports
- VSP System Mandible Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual13 reports
- NA 03.505.007Synthes GmbH · DRIVER, WIRE, AND BONE DRILL, MANUAL6 reports
- VSP System Intermediate Surgical Splint3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual6 reports
- VSP System Fibula Cutting Guide with Implant Placement3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual6 reports
- VSP System Fibula Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual5 reports
- VSP System Maxilla Cutting Guide3d Systems, Inc. · Driver, Wire, And Bone Drill, Manual4 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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