MatrixMANDIBLE 04.503.640.01Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587022161), received between Jul 28, 2022 and May 11, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Break

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERTING THE SCREW, THE SCREW WAS BROKEN, ALL THE PIECES WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143372 ↗
• MalfunctionDec 14, 2023Off-Label Use; Device-Device Incompatibility; Off-Label Use; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT AN OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A STERNAL FRACTURE WAS PERFORMED ON AN UNKNOWN DATE. ALTHOUGH IT WAS AN OFF-LABEL USE, THE PRODUCT WAS USED IN SURGERY AT THE DISCRETION OF THE SURGEON. DURING THE SURGERY, AN EVENT THAT APPEARED TO BE A LOCKING FAILURE OCCURRED. THE SURGEON GAVE UP USING THE PRODUCT AND CHANGED THE PROCEDURE TO A FIXATION USING A WIRE, AND COMPLETED THE SURGERY SUCCESSFULLY WITH NO DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326287 ↗
• InjuryOct 7, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM BRAZIL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 THE SURGEON REMOVED THE IMPLANTS FROM THE FIRST SURGERY AS THE IMPLANTS WERE DAMAGED INSIDE THE PATIENT. NO INFORMATION IS KNOWN ON PATIENT STATUS. THIS REPORT IS FOR A 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM. THIS IS REPORT 9 OF 9 FOR (B)(4).

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15562636 ↗
• InjuryOct 7, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM BRAZIL REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 THE SURGEON REMOVED THE IMPLANTS FROM THE FIRST SURGERY AS THE IMPLANTS WERE DAMAGED INSIDE THE PATIENT. NO INFORMATION IS KNOWN ON PATIENT STATUS. THIS REPORT IS FOR A 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM. THIS IS REPORT 8 OF 9 FOR (B)(4).

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15562564 ↗
• InjuryOct 5, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED (B)(6) 2022 THE SURGEON REMOVED THE IMPLANTS FROM THE FIRST SURGERY AS THE IMPLANTS WERE DAMAGED INSIDE THE PATIENT. NO INFORMATION IS KNOWN ON PATIENT STATUS. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS REPORT IS FOR 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 15543299 ↗
• MalfunctionJul 28, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A MANDIBULAR AREA RESECTION FOR TREATING AMELOBLASTOMA, THE SCREW IN QUESTION WAS PLACED INTO THE SCREW STAND AND GOT STUCK. THE NURSE ATTEMPTED TO DETACH THE SCREW FROM THE STAND, BUT COULD NOT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT SCREW. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15124875 ↗