Matrix 04.511.421Recalls & reported problems
Synthes GmbH · TI MATRIX SAGITTAL SPLIT PLATE STRAIGHT/4 HOLES/6MM BAR · Class 2 · Implant
All models of Matrix (80)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587024370), received between Aug 13, 2021 and Oct 21, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Slipped” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K083388); they may or may not involve this specific model.
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
- Device Slipped2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2021Device Slipped; Device Slipped
IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL OF AN UNKNOWN ORTHOGNATHIC PLATE AND SCREWS DUE TO ORIGINAL FIXATION WAS LOOSENED CAUSING THE PATIENT OCCLUSION TO SHIFT. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) TI MATRIX SAGITTAL SPLIT PLATE STRAIGHT/4 HOLES/6MM BAR.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12672502 ↗InjuryAug 13, 2021Device Slipped; Device Slipped
IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT THE REMOVAL OF AN UNKNOWN ORTHOGNATHIC PLATE AND SCREWS DUE TO ORIGINAL FIXATION WAS LOOSENED CAUSING THE PATIENT OCCLUSION TO SHIFT. THE PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) TI MATRIX SAGITTAL SPLIT PLATE STRAIGHT/4 HOLES/6MM BAR. THIS IS REPORT 9 OF 9 FOR (B)(4).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12319976 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K083388. One submission often covers many models, so check the product and lot details in each record.
- Z-2272-2015 · Jun 24, 2015 · TerminatedSynthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixati
Other PLATE, BONE devices
- MatrixNEURO 04.503.104.01Synthes GmbH · PLATE, BONE252 reports
- 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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