MatrixMANDIBLE 04.503.442.01Recalls & reported problems
Synthes GmbH · 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 12MM · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587020914), received between Nov 7, 2023 and Nov 7, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent1
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.
MalfunctionNov 7, 2023Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, WHILE THE SCRUB NURSE WAS LOADING 2.4MM NON-LOCKING SCREWS FOR THE CASE, INCORRECT SCREW LENGTHS WERE FOUND IN THE CADDIES. ADDITIONALLY, ONE SCREW HEAD APPEARED STRIPPED/DAMAGED. THERE WAS NO SURGICAL DELAY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT IMPACT. THIS REPORT IS FOR A 2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 12MM. THIS IS REPORT 1 OF 1 FOR (B)(4) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18083905 ↗
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- TruMatch SD980.016Materialise NV · Plate, Bone55 reports
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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