NA 201.928ERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10887587028644), received between Dec 21, 2017 and Jan 19, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2024Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION/INTERNAL FIXATION FOR A MANDIBLE FRACTURE ON (B)(6) 2024, AN INTERMEDULLARY FIXATION (IMF) SCREW BROKE OFF INTO A PATIENT. ONLY A PORTION OF THE SCREW WAS ABLE TO BE REMOVED. THE SCREW DID NOT BREAK OFF AT THE HEAD, IT BROKE OFF IN THE MIDDLE OF THE SCREW BODY AND HAD TO BE DRILLED OUT AND ONLY A PORTION WAS ABLE TO BE REMOVED. THERE WAS A SURGICAL DELAY OF 45 MINUTES, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WILL BE MONITORED FOR CONSEQUENCES RELATED TO THE EVENT. THIS REPORT INVOLVES ONE 2.0MM IMF SCREW SELF-DRILLING 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18543366 ↗
• MalfunctionOct 10, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING SURGERY FOR A LEFT MANDIBLE ANGLE FRACTURE, THE 2.0MM IMF (INTERMAXILLARY FIXATION) SCREW HEAD BROKE OFF WHILE BEING INSERTED INTO PATIENT. THE HEAD WAS REMOVED, AND THE THREADS OF THE SCREW REMAINED IN THE PATIENT¿S LOWER JAW. THE IMF SCREWS WERE BEING USED TO PUT THE PATIENT INTO OCCLUSION. THE THREADS OF THE REMAINING SCREW WERE FILED DOWN AND SMOOTHED OVER, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THIS REPORT INVOLVES ONE 2.0MM IMF SCREW SELF-DRILLING 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17906893 ↗
• MalfunctionMay 15, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON APRIL 28, 2023, IMF SCREW BROKE DURING INSERTION. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT OUTCOME IS STABLE. NO FRAGMENTS GENERATED. THIS REPORT IS FOR ONE (1) 2.0MM IMF SCREW SELF-DRILLING 8MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16934703 ↗
• MalfunctionSep 27, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A SURGICAL PROCEDURE DUE TO MANDIBLE FRACTURE. WHILE THE SCREW WAS BEING INSERTED AND TIGHTENED THE IMF SCREW BROKE IN HALF. FRAGMENTS WERE GENERATED AND SCREW WAS BURRED OUT. SURGEON NEEDED TO BURR SCREW OUT SINCE THE TOP OF THE SCREW WAS OFF. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF TEN(10) MINUTES. NO PATIENT CONSEQUENCE. CONCOITANT DEVICE REPORTED: UNK - SCREWDRIVER (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) 2.0MM IMF SCREW SELF-DRILLING 8MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12537304 ↗
• MalfunctionDec 20, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING CLOSED REDUCTION IN MANDIBLE, THE INTERMAXILLARY FIXATION (IMF) SCREW BROKE UPON INSERTION. THE BROKEN FRAGMENT WAS LEFT IN THE MANDIBLE. ANOTHER SCREW WAS INSERTED NEXT TO IT. THERE WAS NO SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) 2.0MM IMF SCREW SELF-DRILLING 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8185114 ↗
• MalfunctionJan 17, 2018Break; Break

  IT WAS REPORTED THAT DURING A SURGERY FOR FACIAL TRAUMA ON (B)(6) 2017, WHEN THE SURGEON WAS TRYING TO INSERT A 2.0 MM INTERMAXILLARY FIXATION (IMF) SCREW SELF-DRILLING 8 MM, THE TIP OF IT BROKE OFF IN THE PATIENT'S MANDIBLE. AS THE TIP OF SCREW WAS NOT ABLE TO BE REMOVED IT WAS LEFT IN PATIENT'S MANDIBLE AND THE OTHER HALF OF THE SCREW WAS REMOVED. ANOTHER SCREW WAS AVAILABLE FOR COMPLETION OF THE PROCEDURE. THERE WAS NO SURGICAL DELAY AND THE PATIENT WAS STABLE AFTER THE SURGERY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7201504 ↗
• MalfunctionDec 21, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2017 A 2.0 MM IMF SCREW SELF DRILLING 8 MM BROKE WHEN THE SURGEON WAS TRYING TO INSERT IT IN THE MANDIBLE OF THE PATIENT. THE BROKEN FRAGMENT WAS REMOVED AND THE SURGERY WAS COMPLETED WITHOUT ANY DELAY. THE PATIENT WAS STABLE AFTER THE SURGERY. CONCOMITANT DEVICE REPORTED: SCREWDRIVER (PART # UNKNOWN, LOT # UNKNOWN QTY # UNKNOWN). THIS REPORT IS FOR ONE (1) 2.0MM IMF SCREW SELF-DRILLING 8MM. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7139095 ↗