MatrixMANDIBLE 04.503.440.20Recalls & reported problems
Synthes GmbH · 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 10MM · Class 2 · Implant
All models of MatrixMANDIBLE (79)
Data updated Oct 18, 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 20887587020904), received between Mar 23, 2020 and Mar 23, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Device Slipped” (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 18, 2026.
Most reported problems
Device problems
- Device Slipped1
Patient problems
- Failure of Implant1
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2020Device Slipped; Device Slipped
DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT A REVISION SURGERY DUE TO THE MATRIXMANDIBLE PLATE LOOSENING. THE MATRIXMANDIBLE PLATE WAS BENT IN PLACE AND WAS TIGHTENED WITH MORE SCREWS. THE ORIGINAL IMPLANT DATE WAS ON (B)(6) 2020. ONE (1) 04.503.729, ONE (1) 04.503.440 AND THREE (3) 04.503.436 SCREWS WERE IMPLANTED DURING THE INITIAL SURGERY ON (B)(6) 2020. DURING THE REVISION SURGERY THE FOLLOWING SCREWS WERE USED TO TIGHTEN THE PLATE: TWO (2) 04.503.672 AND ONE (1) 04.503.670. THERE WERE NO ADDITIONAL SCREWS IMPLANTED AND ONLY A PART OF THE PLATE WAS REMOVED. THE PROCEDURE OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 10MM. THIS IS REPORT 3 OF 5 FOR (B)(4).
Patient problems: Failure of Implant; No Code Available
MAUDE report 9865351 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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