NA 201.928Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20887587028634), received between Feb 28, 2019 and Feb 5, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (12 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Break; Entrapment of Device

  IT WAS REPORTED DURING INSERTION, ONE IMF SCREW BROKE. THE HEAD OF THE SCREW BROKE OFF AND WAS REMOVED. THE SHAFT WAS EMBEDDED IN THE PATIENTS BONE AND COULD NOT BE RETRIEVED. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24268350 ↗
• MalfunctionOct 30, 2025Break; Break

  IT WAS REPORTED THAT DURING THE SURGERY, WHEN INSERTING THE SCREW, THE TIP OF THE SCREW 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 23427296 ↗
• MalfunctionOct 16, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A MAXILLOFACIAL SURGERY, A IMF SCREW SNAPPED AND FRACTURED IN HALF DURING INSERTION. THE TIP OF THE IMF SCREW HAS BEEN LEFT IN THE PATIENT AS IT WOULD CAUSE TOO MUCH DAMAGE TO REMOVE. THE BROKEN OFF HEAD WAS REMOVED FROM THE PATIENT AND IS BEING SENT FOR FURTHER TESTING.

  Patient problems: Foreign Body In Patient

  MAUDE report 23317326 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT THE HARDWARE FRACTURE OCCURRED IN DR. (B)(6) RECONSTRUCTION CASE AT HOSPITAL. UPON REMOVING AN IMF SCREW (PRODUCT CODE: 201.928) TO REMOVE THE PATIENT'S MAXILLOMANDIBULAR FIXATION AT THE END OF THE CASE, THE SCREW HEAD BROKE OFF, LEAVING THE BODY OF THE SCREW INSIDE OF THE PATIENT'S MANDIBLE. NO HARM WAS CAUSED TO THE PATIENT, AS WE WERE ABLE TO BURR OUT THE REMAINDER OF THE SCREW WITH A CARBIDE SIDE CUTTING BURR TO REMOVE ALL REMNANTS OF THE SCREW. THERE WAS NO SURGICAL DELAYED AND THE PROCEDURE SUCCESSFULLY COMPLETED. AND THERE WAS PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720275 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THAT DURING THE SURGERY, WHEN INSERTING THE SCREW, THE SCREW BROKE, ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT INVOLVES ONE (1) 2.0MM IMF SCREW SELF-DRILLING 8MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374889 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THAT DURING THE SURGERY, WHEN INSERTING THE SCREW, THE SCREW BROKE, ALL THE PIECES WERE REMOVED FROM THE PATIENT. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THIS REPORT INVOLVES ONE (1) 2.0MM IMF SCREW SELF-DRILLING 8MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374785 ↗
• MalfunctionApr 1, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWEDEN AS FOLLOWS: IT WAS REPORTED THAT IN (B)(6) 2024, DURING A HIP SURGERY, THE BOX WITH THE CORAIL STEM WITH COLLAR, DID NOT CONTAIN A STEM WITH COLLAR. THE WRONG IMPLANT WAS IN THE BOX. THIS REPORT INVOLVES ONE (1) 2.0MM IMF SCREW SELF-DRILLING 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19013178 ↗
• MalfunctionJan 23, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THE ANCHOR BROKE. IT WAS REPORTED THAT DURING THE SURGERY ,THE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER ONE WAS USED TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. 2.0MM IMF SCREW SELF-DRILLING 8MM-5PK. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16226140 ↗
• MalfunctionJan 23, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THE ANCHOR BROKE. IT WAS REPORTED THAT DURING THE SURGERY ,THE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER ONE WAS USED TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. 2.0MM IMF SCREW SELF-DRILLING 8MM-5PK. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16226055 ↗
• InjuryJun 13, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IN THE PAST 4 (FOUR) WEEKS, THE SURGEON HAD (TEN) 10 DIFFERENT ITEMS SCREWS INCLUDING THE SCREW SELF-DRILLING 8MM BROKE. IT IS UNKNOWN HOW MANY SCREWS WERE BROKEN. FRAGMENTS WERE GENERATED FROM BROKEN DEVICES HAD TO DRILL OUT. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED JUST HAD TO PUT IN ANOTHER SCREW. PATIENT OUTCOME HAD TO LEAVE SOME OF THE BROKEN SCREW INSIDE THE TISSUE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8697988 ↗
• MalfunctionJun 7, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING DENTAL SURGERY AND INTRAMAXILLARY FIXATION, THREE (3) INTRAMAXILLARY FIXATION SCREWS BROKE. THE PATIENT HAD A MANDIBLE FRACTURE. THE SCREWS WERE REMOVED. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN PRECUT CERCLAGE WIRES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: UNKNOWN). THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679687 ↗
• MalfunctionJun 7, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING DENTAL SURGERY AND INTRAMAXILLARY FIXATION, THREE (3) INTRAMAXILLARY FIXATION SCREWS BROKE. THE PATIENT HAD A MANDIBLE FRACTURE. THE SCREWS WERE REMOVED. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN PRECUT CERCLAGE WIRES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: UNKNOWN). THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679647 ↗
• MalfunctionJun 7, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING DENTAL SURGERY AND INTRAMAXILLARY FIXATION, THREE (3) INTRAMAXILLARY FIXATION SCREWS BROKE. THE PATIENT HAD A MANDIBLE FRACTURE. THE SCREWS WERE REMOVED. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN PRECUT CERCLAGE WIRES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY: UNKNOWN). THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8679615 ↗
• MalfunctionFeb 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE HOLDING SLEEVE OF THE INTERMAXILLARY FIXATION (IMF) SCREW DID NOT HOLD THE HEAD OF THE SCREWS WELL; WHEN THE SCREWS WERE PLACED THEY MOVE A LOT, MAKING PLACEMENT DIFFICULT. IT WAS NOTED A LOT OF FORCE WAS PLACED ON TWO (2) SELF-DRILLING INTERMAXILLARY FIXATION (IMF) SCREWS TO PLACE THEM. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS REPORT IS FOR AN INTERMAXILLARY FIXATION (IMF) SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8377909 ↗