MatrixMIDFACE 04.503.373Recalls & reported problems
Synthes GmbH · TI MATRIXMIDFACE ORBITAL RIM PLATE/12 HOLES/0.7MM THICK · Class 2 · Implant
All models of MatrixMIDFACE (40)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587020167), received between May 11, 2026 and May 11, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
1 other recall cover devices cleared under the same FDA submission (K050608); 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Device-Device Incompatibility1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2026Break; Device-Device Incompatibility; No Apparent Adverse Event
IT WAS REPORTED THAT THE MATRIX MIDFACE CADDY BROKEN AND PLATES FELL OUT WITH TRANSPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25143550 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K050608. One submission often covers many models, so check the product and lot details in each record.
- Z-2739-2020 · Jun 16, 2020 · TerminatedMatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive proced
Other SCREW, FIXATION, INTRAOSSEOUS devices
- MatrixMIDFACE 04.503.226.01Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS21 reports
- NA 400.736ESynthes GmbH · SCREW, FIXATION, INTRAOSSEOUS21 reports
- NA 201.928Synthes GmbH · SCREW, FIXATION, INTRAOSSEOUS14 reports
- OsteoMed 204-1206Osteomed LLC · SCREW, FIXATION, INTRAOSSEOUS14 reports
- LEVEL ONE CMF 25-092-12-91KLS-Martin L.P. · SCREW, FIXATION, INTRAOSSEOUS11 reports
- OsteoMed 202-2016Osteomed LLC · SCREW, FIXATION, INTRAOSSEOUS9 reports
- LEVEL ONE CMF 25-092-08-91KLS-Martin L.P. · SCREW, FIXATION, INTRAOSSEOUS9 reports
- PlusDrive 401.062ESynthes GmbH · SCREW, FIXATION, INTRAOSSEOUS8 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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