MatrixMANDIBLE 03.503.081Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587011943), received between Jul 22, 2022 and Aug 18, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 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 SSRO, THE SCREW WAS NOT ABLE TO BE INSERTED WITH THE SCREWDRIVER. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING REPLACEMENT PRODUCTS. THE SURGEON ASSUMED THAT THE EVENT MIGHT HAVE BEEN TRIGGERED BY THE SCREWDRIVER RATHER THAN THE SCREW. THERE WAS NO REPORTED ADVERSE PATIENT OUTCOME. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXMANDIBLE SCREWDRIVER BLD SELF-RETAINING/90 DEGREE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254260 ↗
• MalfunctionAug 18, 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 SSRO, THE SCREW WAS NOT ABLE TO BE INSERTED WITH THE SCREWDRIVER. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING REPLACEMENT PRODUCTS. THE SURGEON ASSUMED THAT THE EVENT MIGHT HAVE BEEN TRIGGERED BY THE SCREWDRIVER RATHER THAN THE SCREW. THERE WAS NO REPORTED ADVERSE PATIENT OUTCOME. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXMANDIBLE SCREWDRIVER BLD SELF-RETAINING/90 DEGREE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254188 ↗
• MalfunctionJul 22, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, TWO OF THE SCREWDRIVERS IN QUESTION WERE TESTED TO CHECK FOR PRODUCT ISSUES PRIOR TO A PROCEDURE SCHEDULED FOR (B)(6) 2022. IN THE PAST, WHILE THE SCREWDRIVER BLADE (03.503.081) WAS ATTACHED TO THE 90° SCREWDRIVER SHAFT (03.503.003) AND GRASPING A SCREW, THE BLADE AND SHAFT WOULD EASILY SEPARATE WHEN PULLING TO RELEASE THE SCREW. BOTH SCREWDRIVERS WERE TESTED, AND THE ISSUE WAS ONLY DISCOVERED ON A SINGLE UNIT. THERE IS NO PATIENT INVOLVEMENT, NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MATRIXMANDIBLE SCREWDRIVER BLD SELF-RETAINING/90 DEGREE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085669 ↗