MatrixMANDIBLE 04.503.705Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587022567), received between Aug 14, 2018 and Aug 14, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

• InjuryAug 14, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH THE A TWELVE-HOLE MATRIXMANDIBLE PLATE ON (B)(6) 2018, AS A REVISION TO A PRIOR BROKEN FOUR-HOLE MATRIXMANDIBLE PLATE. THE TWELVE-HOLE MATRIXMANDIBLE PLATE ALSO BROKE POSTOPERATIVELY ON AN UNKNOWN DATE. AN X-RAY TAKEN ON (B)(6) 2018 REVEALED THE BROKEN PLATE. THE REVISION SURGERY SCHEDULE IS STILL UNKNOWN. THE PATIENT CONSEQUENCES ARE UNKNOWN. THIS REPORT ADDRESSES SECOND REVISION SURGERY DUE TO POSTOPERATIVE BROKEN PLATE. THE FIRST REVISION SURGERY DUE TO BROKEN PLATE HAS BEEN REPORTED UNDER LINKED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) TI MATRIXMANDIBLE 12 HOLE ADAPTION PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7782300 ↗