MatrixMANDIBLE SD449.510BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587004747), received between Nov 16, 2017 and Nov 16, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 16, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A SURGERY ON (B)(6) 2017, A SURGEON DIDN'T FIND THE WHOLE MANDIBLE KIT TO BE PROPERLY FUNCTIONAL. THE TITANIUM (TI) PSPC MATRIXMANDIBLE 7X23H ANGLE RECON PLATE/LEFT/2.5 MM WAS BENT TO THE MODEL BUT NOT AS PER THE STANDARDS. THE SURGEON HAD TO RE-BEND THE PLATE WHICH CAUSED ALMOST 45 MINUTES TO 1 HOUR OF SURGICAL DELAY. THE PLANNED OUTCOME MODEL MANDIBLE, CLEAR DIDN'T SIT RIGHT. ALSO, THE APPEARANCE OF THE ANATOMICAL MODEL SPECIALTY/MEDIUM/CLEAR WAS NOT AS PER THE SURGEON'S REQUIREMENTS. THE SURGERY WAS COMPLETED WITH STABLE PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) TI PSPC MATRIXMANDIBLE 7X23H ANGLE RECON PL/LEFT/2.5 MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7037194 ↗