MatrixMANDIBLE SD449.511BRecalls & reported problems
Synthes GmbH · TI PSPC MATRIXMANDIBLE 7X23H ANGLE RECON PL/RIGHT/2.5MM · Class 2 · Implant
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 10887587004778), received between Apr 1, 2020 and Apr 1, 2020 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAS HAD A CYCLE OF INFECTIONS SINCE SURGERY. THE BONEY FLAP CALCIFIED AND PROPERLY UNIONIZED BUT THERE WERE ISSUES OF INFECTION AFTER THE CASE. THE PLATE HAS NOT BEEN EXPLANTED AND THERE WAS NO PLAN TO REMOVE THE IMPLANTED HARDWARE. THE SURGEON MENTIONED THAT SINCE IT WAS AN INSISTENT PROBLEM AND JUST WANTED TO CONFIRM THAT THERE WERE NO METALS. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Unspecified Infection
MAUDE report 9912254 ↗
Other PLATE, BONE devices
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- 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
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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