NA 201.932ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587028668), received between May 15, 2018 and Nov 22, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionNov 22, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2024 THE ITEM WAS BROKE IN PATIENT¿S MANDIBLE. ONE PART REMAINED IN THE PATIENT AND THE OTHER HALF WAS REMOVED. UNKNOWN IMPLANT AND EXPLANT DATES.

  Patient problems: Foreign Body In Patient

  MAUDE report 20758320 ↗
• InjuryMay 15, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE TO REPAIR A MANDIBLE FRACTURE ON (B)(6) 2018. DURING THE PROCEDURE, WHILE THE SURGEON WAS IMPLANTING A 12MM INTRAMAXILLARY FIXATION (IMF) SCREW INTO THE PATIENT'S BONE, THE SCREW BROKE. THE SURGEON THEN ATTEMPTED TO IMPLANT A SECOND 12MM SCREW; HOWEVER, THAT BROKE AS WELL. THERE WAS A DELAY OF 4-5 MINUTES WHILE THE SURGEON TRIED TO REMOVE THE BROKEN FRAGMENTS, BUT THE SURGEON EVENTUALLY DECIDED TO LEAVE THE FRAGMENTS IMPLANTED. THE SURGEON COMPLETED THE SURGERY USING ARCH BARS. CONCOMITANT DEVICES REPORTED: SCREWDRIVER (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), 12MM X 2.0MM IMF SCREWS (PART 201.932E, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 2.0MM IMF SCREW SELF-DRILLING 12MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7515476 ↗
• InjuryMay 15, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE TO REPAIR A MANDIBLE FRACTURE ON (B)(6) 2018. DURING THE PROCEDURE, WHILE THE SURGEON WAS IMPLANTING A 12MM INTRAMAXILLARY FIXATION (IMF) SCREW INTO THE PATIENT'S BONE, THE SCREW BROKE. THE SURGEON THEN ATTEMPTED TO IMPLANT A SECOND 12MM SCREW; HOWEVER, THAT BROKE AS WELL. THERE WAS A DELAY OF 4-5 MINUTES WHILE THE SURGEON TRIED TO REMOVE THE BROKEN FRAGMENTS, BUT THE SURGEON EVENTUALLY DECIDED TO LEAVE THE FRAGMENTS IMPLANTED. THE SURGEON COMPLETED THE SURGERY USING ARCH BARS. CONCOMITANT DEVICES REPORTED: SCREWDRIVER (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), 12MM X 2.0MM IMF SCREWS (PART 201.932E, LOT NUMBER UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 2.0MM IMF SCREW SELF-DRILLING 12MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7515440 ↗